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

Model Number	24681
Date of Event	09/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon failed to deflate.This 5.0 x 40, 135cm charger balloon and non-boston scientific 5f introducer was selected for treatment of spinal muscle atrophy of the celiac truck.The procedure went as expected; however, during removal the balloon was not able to be deflated.The physician was unsuccessful at attempting to use a "dilator handle" to remove.At last, they withdrew the balloon together with the introducer.This caused a bigger "entrance hole" than normal and took additional time and sutures to close the access point.The patient was reported as fully recovered.
Event or Problem Description
It was reported that the balloon failed to deflate.This 5.0 x 40, 135cm charger balloon and non-boston scientific 5f introducer was selected for treatment of spinal muscle atrophy of the celiac truck.The procedure went as expected; however, during removal the balloon was not able to be deflated.The physician was unsuccessful at attempting to use a "dilator handle" to remove.At last, they withdrew the balloon together with the introducer.This caused a bigger "entrance hole" than normal and took additional time and sutures to close the access point.The patient was reported as fully recovered.
Additional Manufacturer Narrative
Device eval by manufacturer: this 5.0 x 40, 135cm charger balloon was returned and analyzed.Visual examination found no issue with the tip of the device or marker bands.The balloon was not folded, which indicates that it was subjected to positive pressure and had been inflated.A visual and tactile examination found that the shaft was free from kinks or damage.Functional analysis was performed, where the balloon was inflated to its rated burst pressure using deionizes water and an inflation unit.A vacuum was then applied, and the balloon was fully deflated in less than 10 seconds.The inflation device was verified at 20 atmospheres, before and after use with a calibrated pressure gauge.This inflation to rated burst pressure and deflation was repeated three times with full balloon deflation of the balloon being achieved in less than 10 seconds on every occasion.The report of the balloon failure to deflate was not confirmed through analysis.

• Brand Name: CHARGER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20361430
• Report Number: 2124215-2024-58714
• Device Sequence Number: 7836327
• Product Code: LIT
• UDI-Device Identifier: 08714729804246
• UDI-Public: 08714729804246
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

1 Device 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 Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0033946782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial