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

Model Number	24628
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 75% stenosed target lesion was located in left cephalic vein.A 6.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During procedure, at inflation, it was noted that the balloon ruptured below nominal pressure a 6 atmosphere in less 10 seconds.There were no bend in the vessel.The device was removed from the patient body difficulty through the sheath that was placed initially arteriovenous (av) fistula vein.The procedure was completed with another of same bsc balloon device.No patient injury or complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.A 75% stenosed target lesion was located in left cephalic vein.A 6.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During procedure, at inflation, it was noted that the balloon ruptured below nominal pressure a 6 atmosphere in less 10 seconds.There were no bend in the vessel.The device was removed from the patient body difficulty through the sheath that was placed initially arteriovenous (av) fistula vein.The procedure was completed with another of same bsc balloon device.No patient injury or complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A visual examination identified that there was blood in the balloon material which suggests that there is a leak in the device.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from two balloon pinholes, one was detected approximately 6mm proximal of the proximal edge of the distal markerband and the other pinhole was detected at the distal edge of the proximal markerband.An examination of the balloon material identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed that approximately 1mm of one of the cutting blades is slightly lifted from the balloon material at the proximal end.No other damage or issues were noted with the blades that could have contributed to the complaint incident.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the markerbands.A visual and tactile examination identified no issues with the shaft which may have potentially contributed to the complaint incident.No other issues were identified during the product analysis.

• Brand Name: 2CM PERIPHERAL CUTTING BALLOON
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8880858
• Report Number: 2134265-2019-09552
• Device Sequence Number: 10826447
• Product Code: PNO
• UDI-Device Identifier: 08714729813736
• UDI-Public: 08714729813736
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K151253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/29/2021
• Device Model Number: 24628
• Device Catalogue Number: 24628
• Device Lot Number: 0023268445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 09/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR