FDA Adverse Event Injury Summary report: N

POLARCATH

MDR report key: 3021210 · Received March 26, 2013

Report

Report Number: 2134265-2013-01822
Event Type: Injury
Date Received: March 26, 2013
Report Date: February 27, 2013
Manufacturer: BOSTON SCIENTIFIC - SAN JOSE
Product Code: DQY
PMA / PMN Number: K060572
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GR
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CITATION: SPILIOPOULOU, SRAVROS. ET AL (2010). CRYOPLASTY VERSUS CONVENTIONAL BALLOON ANGIOPLASTY OF THE FEMOROPOPLITEAL ARTERY IN DIABETIC PATIENTS: LONG-TERM RESULTS FROM A PROSPECTIVE RANDOMIZED SINGLE-CENTER CONTROLLED TRIAL. SPRINGER SCIENCE+BUSINESS MEDIA, LLC AND THE CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGICAL SOCIETY OF EUROPE. 2010. DOI 10.1007/S00270-010-9915-X. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN; THEREFORE, THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

Description of Event or Problem · 1

SAME CASE AS 2134265-2013-01748, 2134265-2013-01823, 2134265-2013-01824, 2134265-2013-01826. IT WAS REPORTED VIA A JOURNAL ARTICLE THAT DURING A CRYOPLASTY PROCEDURE A VESSEL DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE FEMOROPOPLITEAL ARTERY OF A DIABETIC PATIENT. DURING THE PROCEDURE A FLOW LIMITING DISSECTION OCCURRED. THE DISSECTION WAS TREATED WITH A SECOND CRYOPLASTY APPLICATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
124753	POLARCATH	CATHETER, PERCUTANEOUS	DQY	BOSTON SCIENTIFIC - SAN JOSE	UNK319

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other