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

Model Number	24681
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon deflation failure occurred and removal difficulties were encountered.The 90% stenosed target lesion was located in the iliac vein.A 10.0 x80, 75cm charger balloon catheter was advanced and successfully inflated.However, it was noted that after multiple attempts and waiting for two minutes, the balloon could not be withdrawn.Subsequently, the balloon was punctured through the body surface with a needle and the contrast agent was extracted.The delivery shaft was then cut off and withdrawn.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that balloon deflation failure occurred and removal difficulties were encountered.The 90% stenosed target lesion was located in the iliac vein.A 10.0 x80, 75cm charger balloon catheter was advanced and successfully inflated.However, it was noted that after multiple attempts and waiting for two minutes, the balloon could not be withdrawn.Subsequently, the balloon was punctured through the body surface with a needle and the contrast agent was extracted.The delivery shaft was then cut off and withdrawn.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.It was further reported that the device was used to pre-dilate the lesion during stenting procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.The device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A microscopic examination identified a balloon pinhole located approximately 30mm proximal of the distal markerband.A visual and microscopic examination identified no issues with the tip.A visual and tactile examination found the shaft to be completely detached at approximately 10mm distal of the strain relief.As the shaft shows no indication of stretching, detachment may have been due to the shaft encountering a sharp object.The investigator dissected the device to inspect the lap weld for any blockages and none were found.Due to the condition of the returned device it was not possible to flush the device in the normal fashion, due to the detachment of the hub.As a result, an inflation aid (flushing needle) was attached to the distal section of the detached shaft.This facilitated the connection of the boston scientific encore inflation unit which allowed the shaft to be flushed without issue.No blockages were identified in the distal section of the shaft.During analysis the investigator attached a boston scientific encore inflation device to the inflation port of the charger device and successfully flushed the hub.This would indicate that there was no blockage present in the hub or proximal section of detached shaft.No other issues were identified during the product analysis.

• 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: 8790017
• Report Number: 2134265-2019-08152
• Device Sequence Number: 2638232
• Product Code: FGE
• UDI-Device Identifier: 08714729803812
• UDI-Public: 08714729803812
• 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): 08/20/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2022
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0023577908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Initial Date Received by Manufacturer: 07/05/2019
• Supplement Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR