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

Model Number 24681

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2022

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(6) 2022.It was reported that balloon leak occurred.The severely stenosed target lesion was located in iliac vein.A 10.0 x80, 75cm charger balloon catheter was advanced for dilatation.However, during the procedure, the balloon was leaking contrast.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.However, returned device analysis revealed the balloon was torn longitudinally.

Manufacturer Narrative

Device evaluated by mfr.: a visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A balloon longitudinal tear was identified beginning approximately 19mm distal of the proximal markerband and extending approximately 5mm distally across the balloon material.No issues were noted with the tip or markerbands of the device and no kinks or damage were noted along the shaft of the device.No other issues were identified during the product analysis.

• Brand Name: CHARGER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15341096
• MDR Text Key: 303067329
• Report Number: 2124215-2022-31339
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729803812
• UDI-Public: 08714729803812
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K112697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/01/2022

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
• Device Operator: Health Professional
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0027916282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2022
• Initial Date FDA Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Sex: Female