MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MUSTANG; CATHETER, BILIARY, DIAGNOSTIC

Model Number	24674
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that balloon deflation failure occurred.A 6.0 x 20, 75 cm mustang balloon catheter was advanced for dilation.However, it was noted that the balloon was not able to deflate and had to use a needle to poke and draw the contrast for it to deflate.The procedure was completed no patient complications reported.
Additional Manufacturer Narrative
D4.Lot number: corrected from 25943767 to 25819493.D4.Expiration date: correction from 08/31/2023 to 08/06/2023.D4.Unique identifier (udi) #: corrected from (b)(4).H4: device manufacture date corrected from 08/31/2020 to 08/06/2020.Device evaluated by mfr: a mustang 6 x 2,75cm was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was present in the balloon which is indicative of a leak.The investigator was unable to inflate the balloon as the device was received back in two sections.An examination of the balloon material identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device as per mustang specification is 24 atmospheres.A visual and microscopic examination observed no damage to the tip of the device.A visual and tactile examination found the shaft of the device to have completely detached 9mm distally from the distal end of the strain relief.A visual and microscopic examination of the marker bands identified no issues which may potentially have contributed to the complaint incident.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon deflation failure occurred.A 6.0 x 20, 75 cm mustang balloon catheter was advanced for dilation.However, it was noted that the balloon was not able to deflate and had to use a needle to poke and draw the contrast for it to deflate.The procedure was completed no patient complications reported.It was further reported that the 75% stenosed with less than 90 degrees bend target lesion was located in a non-calcified and non tortuous around anastomosis vessel.The balloon was inflated to 24 atmospheres.The balloon was in deflated state when removed as it was punctured with a needle.The procedure was completed with another 6 mm x 20 mm, 75 cm mustang balloon catheter.The device was completely removed from the patient and the patient's status was stable.
Additional Manufacturer Narrative
B3 - date of event: corrected from (b)(6) 2020 to (b)(6) 2020.E1 - initial reporter phone corrected from (b)(6) to (b)(6).
Event or Problem Description
It was reported that balloon deflation failure occurred.A 6.0 x 20, 75 cm mustang balloon catheter was advanced for dilation.However, it was noted that the balloon was not able to deflate and had to use a needle to poke and draw the contrast for it to deflate.The procedure was completed no patient complications reported.It was further reported that the 75% stenosed with less than 90 degrees bend target lesion was located in a non-calcified and non tortuous around anastomosis vessel.The balloon was inflated to 24 atmospheres.The balloon was in deflated state when removed as it was punctured with a needle.The procedure was completed with another 6 mm x 20 mm, 75 cm mustang balloon catheter.The device was completely removed from the patient and the patient status was stable.

• Brand Name: MUSTANG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11007908
• Report Number: 2134265-2020-17698
• Device Sequence Number: 3813950
• Product Code: FGE
• UDI-Device Identifier: 08714729793397
• UDI-Public: 08714729793397
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2021

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: 08/06/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0025819493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 12/17/2020; 02/08/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 01/06/2021; 03/02/2021
• 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