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

Model Number	24681
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon detachment occurred.The target lesion was located in the popliteal vein.A 8.0 x40, 135cm charger balloon catheter was was selected to dilate the lesion.The balloon was inflated three times, between 8 and 10 atmospheres each time.The physician attempted to withdraw the balloon out of the 6fr short non-bsc sheath but the balloon would not come out.The physician continued to pull on it and the balloon detached from the shaft inside the sheath.The sheath was removed which had the detached balloon stuck in it and everything was removed together.The procedure was completed with this device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: visual examination of the returned device identified that the balloon was not folded, indicating the balloon was subjected to positive pressure.A longitudinal tear was observed on the balloon beginning approximately 8mm distal of the proximal markerband, extending approximately 7mm distally across the balloon material.A visual and microscopic examination identified no damage to the tip of the device.A visual and tactile examination of the shaft revealed the shaft was stretched and completely detached approximately 3mm proximal of the proximal balloon bond.This type of damage is consistent with excessive tensile force being applied when attempting to remove the device from the patient.Functional testing revealed the balloon was unable to advance through a 6fr bsc sheath due to the condition of the shaft and the balloon material.No other issues were noted with the device that could potentially have contributed to the complaint incident.
Event or Problem Description
It was reported that balloon detachment occurred.The target lesion was located in the popliteal vein.A 8.0 x40, 135cm charger balloon catheter was was selected to dilate the lesion.The balloon was inflated three times, between 8 and 10 atmospheres each time.The physician attempted to withdraw the balloon out of the 6fr short non-bsc sheath but the balloon would not come out.The physician continued to pull on it and the balloon detached from the shaft inside the sheath.The sheath was removed which had the detached balloon stuck in it and everything was removed together.The procedure was completed with this device.No patient complications were reported.

• 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: 8449846
• Report Number: 2134265-2019-02971
• Device Sequence Number: 344674
• Product Code: FGE
• UDI-Device Identifier: 08714729804666
• UDI-Public: 08714729804666
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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): 04/17/2019

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: 01/08/2022
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0023163385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 04/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTRODUCER SHEATH: 6FR SHORT TERUMO; INTRODUCER SHEATH: 6FR SHORT TERUMO