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

Model Number M001BP90820B0

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that a cutting balloon blade was hanging off.An 8.00mm / 2.0cm / 90cm 2cm peripheral cutting balloon¿ was used to treat a fistula containing a previously implanted stent.After removing the balloon from the sheath after use, it was noticed that one of the dermatomes was not completely adhered to the balloon.The procedure was completed with this device.No patient complications were reported and the patient's status was fine.

Manufacturer Narrative

(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).

Manufacturer Narrative

Device evaluated by manufacturer: investigation completed.The device was returned for analysis.A visual examination noted that one blade had detached from the balloon; however, the blade pad was still fully intact.The three remaining blades were fully bonded to the balloon and no damage was noted to the blades.The returned device was attached to an encore inflation unit.Positive pressure was applied.No leak was noted.The balloon was inflated to its rated burst pressure.The balloon inflated and deflated successfully.Visual and tactile examination of the shaft observed no kinks or damage.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 a cutting balloon blade was hanging off.An 8.00mm / 2.0cm / 90cm 2cm peripheral cutting balloon was used to treat a fistula containing a previously implanted stent.After removing the balloon from the sheath after use, it was noticed that one of the dermatomes was not completely adhered to the balloon.The procedure was completed with this device.No patient complications were reported and the patient's status was fine.

• Brand Name: 2CM PERIPHERAL CUTTING BALLOON?
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• 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: 4337158
• MDR Text Key: 5215118
• Report Number: 2134265-2014-07713
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K070951
• 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
• Report Date: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2016
• Device Model Number: M001BP90820B0
• Device Catalogue Number: BP908020B
• Device Lot Number: 0017085957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1