MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number H74939282302010

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2016

Event Type  malfunction  

Manufacturer Narrative

Age at the time of event: 18 years or older. (b)(4). Device evaluated by mfr: the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).

Event Description

It was reported that balloon rupture occurred. The 90% stenosed target lesion was located in the severely calcified superficial femoral artery. A 3. 0mmx20mmx143cm nc quantum apex¿ balloon catheter was used to dilate the lesion. The balloon was initially inflated at 8 atmospheres. Upon the second inflation at 5 atmospheres for 5 seconds, the balloon ruptured. The procedure was completed with a different device. No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr. : returned product consisted of a coyote nc balloon catheter and a stopcock. The balloon was loosely folded with blood in the balloon and inflation lumen. Microscopic inspection and functional testing revealed a pinhole in the balloon material, 2mm proximal of the distal markerband. There is no indication the device was inflated over rbp. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause is operational context as device performance was limited due to anatomical procedural factors. (b)(4).

Event Description

It was reported that balloon rupture occurred. The 90% stenosed target lesion was located in the severely calcified superficial femoral artery. A 3. 0mmx20mmx143cm nc quantum apex¿ balloon catheter was used to dilate the lesion. The balloon was initially inflated at 8 atmospheres. Upon the second inflation at 5 atmospheres for 5 seconds, the balloon ruptured. The procedure was completed with a different device. No patient complications were reported.

• Brand Name: NC QUANTUM APEX¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6184972
• MDR Text Key: 62692453
• Report Number: 2134265-2016-11915
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/06/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/28/2018
• Device Model Number: H74939282302010
• Device Catalogue Number: 39282-30201
• Device Lot Number: 18883047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial