IAB: 8 FR - 40 CC

MDR report key: 3881084 · Received April 7, 2014

Report

Report Number: 1219856-2014-00069
Event Type: Malfunction
Date Received: April 7, 2014
Date of Event: March 14, 2014
Report Date: March 17, 2014
Manufacturer: ARROW INTL., INC.
Product Code: DSP
PMA / PMN Number: K000729
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE EVENT OCCURRED WHILE IN THE CARDIOLOGY DEPARTMENT DURING INSERTION. THE PHYSICIAN ATTEMPTED TO INSERT THE INTRA-AORTIC BALLOON (IAB) THROUGH THE INTRODUCER SHEATH VIA LEFT FEMORAL ARTERY, BUT WAS NOT ABLE TO ADVANCE. THE PHYSICIAN IS SKILLFUL WITH THIS DEVICE AND FOLLOWED THE INSTRUCTIONS FOR USE. THE PHYSICIAN VACUUMED THE IAB PROPERLY INSIDE OF THE TRAY AND IMMERSED THE IAB MEMBRANE IN SALINE PRIOR TO INSERTION. AS A RESULT, THE PHYSICIAN REMOVED THE IAB WITH THE SHEATH AND DECIDED TO REPLACE THEM WITH A NEW KIT. THE PHYSICIAN COMPLETED THE PROCEDURE SUCCESSFULLY WITH THE SECOND KIT VIA THE SAME INSERTION SITE (LEFT FEMORAL ARTERY). PER THE PHYSICIAN THERE WAS NO REPORT OF PT DEATH, COMPLICATION OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THERE WAS AN APPROXIMATE 10 MINUTE DELAY WITH NO HARM TO THE PT. ADDITIONAL INFO RECEIVED STATED A TEFLON SHEATH WAS USED DURING INSERTION. THE PT HAD A LITTLE BIT OF TORTUOUS, BUT NOT SEVERE ANATOMY. THE MEMBRANE WAS WET AND WAS IMMERSED IN SALINE FOR 1 SECOND. THEY WERE NOT SURE EXACTLY THE WAITING TIME BEFORE INSERTING THE IAB, BUT THE PHYSICIAN DID STATE WAITING TO DRY THE IAB FOR A WHILE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
206437	IAB: 8 FR - 40 CC	INTRA-AORTIC BALLOON PRODUCTS	DSP	ARROW INTL., INC.		KF2032646

Patients

Seq	Age	Sex	Outcome	Treatment
1