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

Model Number	24674
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access sites were obtained via ultrasound guided puncture in the left popliteal (pop) vein and the right femoral vein.The target lesion was located in the lower left limb vein.After the guidewire vessel sheaths were placed, a guidewire crossed the lesion and upon reaching the vena cava, the physician placed a filter.The guidewire in the left pop sheath was used for an angiogram in the lower lumen.After the amplatz guidewire was replaced, an angiojet catheter was advanced through the guidewire for power pulse and thrombectomy and the device was withdrawn.The physician then advanced a 12.0 x 80, 75cm mustang balloon catheter through the guidewire for dilatation.However, during the first inflation, there was loss of pressure despite several attempts.The connection was checked and there were no issues.The balloon was removed and it was noted that the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: a 12x8x75 mustang device was returned for analysis.A visual examination identified that the balloon was not folded which indicated that the device was subjected to positive pressure.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 13mm proximal of the proximal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination identified no kinks or damage to the shaft which may have potentially contributed to the complaint incident.A visual and tactile examination identified damage to the tip of the device.This type of damage is consistent with excessive force being applied to the device when attempting to cross the lesion.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access sites were obtained via ultrasound guided puncture in the left popliteal (pop) vein and the right femoral vein.The target lesion was located in the lower left limb vein.After the guidewire vessel sheaths were placed, a guidewire crossed the lesion and upon reaching the vena cava, the physician placed a filter.The guidewire in the left pop sheath was used for an angiogram in the lower lumen.After the amplatz guidewire was replaced, an angiojet catheter was advanced through the guidewire for power pulse and thrombectomy and the device was withdrawn.The physician then advanced a 12.0 x 80, 75cm mustang balloon catheter through the guidewire for dilatation.However, during the first inflation, there was loss of pressure despite several attempts.The connection was checked and there were no issues.The balloon was removed and it was noted that the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient 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: 10130693
• Report Number: 2134265-2020-06592
• Device Sequence Number: 2420877
• Product Code: FGE
• UDI-Device Identifier: 08714729794745
• UDI-Public: 08714729794745
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2020

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: 08/18/2022
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0024290175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2020
• Initial Date Received by Manufacturer: 05/12/2020
• Supplement Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 06/08/2020
• Supplement Report FDA Received Date: 06/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 50