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

Model Number M001PCB5020500

Device Problem Material Rupture (1546)

Patient Problem Perforation of Vessels (2135)

Event Date 04/03/2018

Event Type  Injury  

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).

Event Description

It was reported that a vessel perforation occurred.The more than 70% stenosed target lesion was located in the severely calcified arteriovenous (av) fistula in the left arm.A 5.00mm/2.0cm/50cm peripheral cutting balloon® was selected for use.During the procedure, the 2cm peripheral cutting balloon® ruptured at about 10atm.The patient's vessel then ruptured.The 2cm peripheral cutting balloon® was removed over the wire and a 6x40 sterling balloon was inserted and used at low pressure to control the bleed.The procedure was completed with a different device with a nice result.The patient was asymptomatic throughout with no further complications.Patient was in stable condition post-procedure.

Event Description

It was reported that a vessel perforation occurred.The more than 70% stenosed target lesion was located in the severely calcified arteriovenous (av) fistula in the left arm.A 5.00mm/2.0cm/50cm peripheral cutting balloon® was selected for use.During the procedure, the 2cm peripheral cutting balloon® ruptured at about 10atm.The patient's vessel then ruptured.The 2cm peripheral cutting balloon® was removed over the wire and a 6x40 sterling balloon was inserted and used at low pressure to control the bleed.The procedure was completed with a different device with a nice result.The patient was asymptomatic throughout with no further complications.Patient was in stable condition post-procedure.

Manufacturer Narrative

Device evaluated by mfr.: the tip section of the device was visually and microscopically examined and no issues were noted that could have potentially contributed to the complaint incident.A visual and microscopic examination identified no issues with the blades.All blades were present and fully bonded to the balloon material.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon and inflation lumen which is evidence of a device leak.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon longitudinal tear.The tear was located approximately 7mm distal to the distal end of the proximal markerband and it extended distally for a total length of 2mm.A visual and microscopic examination found no issues with the markerbands of the device.A visual and tactile examination identified no kinks or damage to the shaft of the device.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).

• Brand Name: 2CM PERIPHERAL CUTTING BALLOON®
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7474147
• MDR Text Key: 106953680
• Report Number: 2134265-2018-03465
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/03/2018

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: 03/06/2019
• Device Model Number: M001PCB5020500
• Device Catalogue Number: PCB502050
• Device Lot Number: 0020367333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 04/30/2018
• Supplement Dates Manufacturer Received: 06/20/2018
• Supplement Dates FDA Received: 07/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR