MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SMALL PERIPHERAL CUTTING BALLOON?; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number M001BPM4015140F0

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem Perforation of Vessels (2135)

Event Date 02/12/2015

Event Type  Injury  

Event Description

It was reported that difficulty removing the catheter, balloon detachment, and perforation occurred, leading to intervention and surgery.An unspecified 014 wire was used to access a left superficial femoral artery (sfa) graft through an unspecified 6f introducer sheath.A 4.00mm/1.5cm/140cm small peripheral cutting balloon¿ catheter was selected to treat the sfa graft and inflated three times.Upon removing the catheter, resistance was encountered.The physician pulled hard on the catheter shaft; however, the balloon broke off from the catheter and migrated toward the tibial vessel where it lodged and became stuck.The physician attempted to use a non-bsc snare to capture the balloon; however, this resulted in perforating the graft.The patient bled internally from the rupture.The rupture was sealed using a non-bsc covered stent.Further attempts to recapture the balloon using an unspecified balloon were unsuccessful.The patient underwent surgery to remove the balloon from the vessel.

Manufacturer Narrative

Age at the time of event: approximately (b)(6).(b)(4).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).

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for evaluation.The device was received in three sections with breaks identified at two separate locations; 13.8cm proximal to the tip and 1.325 distal to the strain relief.At the proximal break site the shaft polymer extrusion was severely stretched and tapered down.The shaft polymer extrusion was severely kinked across the length of the distal portion of the device.This damage is consistent with the application of excessive force to the delivery system.An initial examination of the balloon confirmed that all four blades were present and remained bonded to the balloon.However, it was noted during a further microscopic examination that two of the blades were cracked and bent in 2 and 3 separate locations between 12mm and 17mm proximal to the tip.There were no issues noted with the other blades.A visual and tactile examination found that the hypotube was kinked across its length.This damage is consistent with the application of excessive force.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause has been determined to be use/user error as the dfu states: ¿insert a 0.36 mm (0.014 in) guidewire through the peripheral cutting balloon device guidewire lumen.¿ (b)(4).

Event Description

It was further reported that the target lesion was located in the femoral popliteal bypass graft.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the target lesion was located in the femoral popliteal bypass graft.

• Brand Name: SMALL PERIPHERAL CUTTING BALLOON?
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4552406
• MDR Text Key: 5526319
• Report Number: 2134265-2015-01407
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2015
• Device Model Number: M001BPM4015140F0
• Device Catalogue Number: BPM4015140F
• Device Lot Number: 0015659217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention