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

Model Number	24681
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.The target lesion was located in the left femoral vein.A 8.0 x100, 135cm charger balloon catheter was advanced for dilatation.After the last inflation, the balloon was totally deflated; however, when the device was pulled out, the balloon catheter became stuck about half way through the introducer sheath.The catheter broke in two at the connection between the balloon and the catheter.The broken parts were retrieved as it came out with the sheath.Venogram was taken and the procedure was completed.No patient complications were reported.
Event or Problem Description
It was reported that a shaft break occurred.The target lesion was located in the left femoral vein.A 8.0 x100, 135cm charger balloon catheter was advanced for dilatation.After the last inflation, the balloon was totally deflated; however, when the device was pulled out, the balloon catheter became stuck about half way through the introducer sheath.The catheter broke in two at the connection between the balloon and the catheter.The broken parts were retrieved as it came out with the sheath.Venogram was taken and the procedure was completed.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: charger 8.0 x 100, 135 cm device was returned for analysis.A visual examination of the returned device found that the balloon appeared inflated.There were no issues noted on the balloon during a visual and microscopic examination of the balloon material.A visual and microscopic examination of the markerbands identified no issues.A visual and tactile examination found that the shaft was broken at approximately 1225 mm from the distal end of the strain relief, approximately 2mm from the shaft-balloon bond.The shaft appeared stretched at the break site indicating that excessive force could have been applied during withdrawal attempts from the patient's body.A visual and tactile examination identified no damage to the tip.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: 9119523
• Report Number: 2134265-2019-11630
• Device Sequence Number: 14040134
• Product Code: LIT
• UDI-Device Identifier: 08714729804574
• UDI-Public: 08714729804574
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2019

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: 06/19/2022
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0023986399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 11/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR