FDA Adverse Event Injury Summary report: N

KINETIX GUIDEWIRE, PLUS GUIDEWIRE

MDR report key: 1841721 · Received September 22, 2010

Report

Report Number: 2134265-2010-04327
Event Type: Injury
Date Received: September 22, 2010
Date of Event: September 1, 2010
Report Date: September 2, 2010
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: DQX
PMA / PMN Number: K081021
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.(B)(4)

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A VESSEL PERFORATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA). A KINETIX GUIDEWIRE WAS ADVANCED TO THE POSTERIOR DESCENDING ARTERY (PDA) AND A NON BSC GUIDEWIRE WAS ADVANCED TO THE POSTEROLATERAL ARTERY (PLA) AT THE SAME TIME. THE RCA WAS PREDILATED AND THEN, AN UNSPECIFIED STENT WAS DEPLOYED IN THE LESION. BOTH GUIDEWIRES WERE REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THERE WAS "BLUSHING" IN THE LESION AND A "MICRO PERFORATION" OCCURRED FROM THE KINETIX GUIDEWIRE. THE BLEEDING STOPPED WITHIN TEN MINUTES. THE PERFORATION DID NOT REQUIRE ANY TREATMENT AND THE PROCEDURE WAS COMPLETED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	KINETIX GUIDEWIRE, PLUS GUIDEWIRE	WIRE, GUIDE, CATHETER	DQX	BOSTON SCIENTIFIC - MAPLE GROVE	UNK575

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other