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

Model Number	24681
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulties were encountered.The severely stenosed target lesion was located in a vessel in the moderately tortuous and non-calcified biliary tract.A 8.0 x80, 135cm charger balloon catheter was advanced for dilatation.However, during procedure, the balloon could not be withdrawn easily.The procedure was completed with another of same device.There were no complications reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: a charger device 8mm x 80mm, 135cm, 80mm, 18atm was returned for analysis.A visual examination of the returned device identified that the balloon had been inflated and was not refolded.Solidified media was present in balloon.It is not known when the balloon was subjected to positive pressure.The balloon was visually and microscopically examined, and no issues were noted that may have potentially 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 kinks or damage to the shaft of the returned device.No issues were identified during the product analysis.
Event or Problem Description
It was reported that removal difficulties were encountered.The severely stenosed target lesion was located in a vessel in the moderately tortuous and non-calcified biliary tract.A 8.0 x80, 135cm charger balloon catheter was advanced for dilatation.However, during procedure, the balloon could not be withdrawn easily.The procedure was completed with another of same device.There were no complications reported and the patient's status was stable.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: 11806993
• Report Number: 2134265-2021-05739
• Device Sequence Number: 11637807
• Product Code: FGE
• UDI-Device Identifier: 08714729804697
• UDI-Public: 08714729804697
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K112697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2021

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: 11/02/2023
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0026283150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 75