MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CHARGER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24681
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the lower limb vessel.A 12.0 x80, 75cm charger balloon catheter was advanced for dilation.However, during first inflation for few seconds the balloon ruptured, a visible pinhole was noted after a pressure test was performed.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.Device evaluated by mfr: a 12 x 80 charger balloon catheter was returned for analysis.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 pinhole located approximately 13mm proximal of the proximal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 12 atmospheres.A visual and microscopic examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination identified no kinks or damage to the shaft which may have potentially contributed to the complaint incident.A visual and tactile examination identified no damage to the tip which may have potentially contributed to the complaint incident.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the lower limb vessel.A 12.0 x80, 75cm charger balloon catheter was advanced for dilation.However, during first inflation for few seconds the balloon ruptured, a visible pinhole was noted after a pressure test was performed.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.

• Brand Name: CHARGER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9946988
• Report Number: 2134265-2020-04889
• Device Sequence Number: 19002338
• Product Code: FGE
• UDI-Device Identifier: 08714729803881
• UDI-Public: 08714729803881
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K112697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2020

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: 06/11/2022
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0023942044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 05/17/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 06/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1