MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Model Number M001BP35520B0

Device Problems Bent (1059); Detachment Of Device Component (1104)

Patient Problem Pain (1994)

Event Date 06/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the patient felt pain and a blade detached.During a percutaneous transluminal angioplasty (pta) in the superficial femoral artery (sfa) popliteal, the physician was using a 2cm peripheral cutting balloon¿.The patient felt some pain during dilation.The device was being removed with normal resistance from the patient when it was noted the blade lifted.After the device was fully removed from the patient the blade detached from the balloon.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.An examination of the balloon and blade found that the detached blade was measured at 7mm.The balloon was inflated using an encore inflation device to get a better view of the blades.It was noted that 7mm of blade had partially detached from the proximal end of one of the blades on the balloon.The remaining 13mm of the blade and pad was undamaged.The remaining blades on the device were analyzed and no issues were noted.No issues were noted with the shaft polymer extrusion.A visual and tactile examination of the hypotube found no kinks or damage along the shaft of the device.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 is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported the patient felt pain and a blade detached.During a percutaneous transluminal angioplasty (pta) in the superficial femoral artery (sfa) popliteal, the physician was using a 2cm peripheral cutting balloon.The patient felt some pain during dilation.The device was being removed with normal resistance from the patient when it was noted the blade lifted.After the device was fully removed from the patient the blade detached from the balloon.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.

• Brand Name: 2CM PERIPHERAL CUTTING BALLOON¿
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5774740
• MDR Text Key: 48922180
• Report Number: 2134265-2016-06141
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K070951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2017
• Device Model Number: M001BP35520B0
• Device Catalogue Number: BP1355020B
• Device Lot Number: 18315732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2016
• Initial Date FDA Received: 07/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2015
• 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): Other