MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MACH1; CATHETER, PERCUTANEOUS

Model Number	1260
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: event date was not reported and was approximated to (b)(6) 2021.
Event or Problem Description
It was reported that dissections occurred and additional intervention was required.Two 6f mach1 guide catheters were selected for use for the procedure.The mach1 guide catheters did not sufficiently support balloon or stent advancement in small, tough lesions and tortuous veins.The devices lost their hardness over time.In some cases, the mach1 guide catheters would stick to the insertion site sheath and would move the sheath during catheter movements.It was observed to lack inner diameter suitability to practically support easy double balloon or joint stent-balloon advancement.Additional steps, such as embedding the catheter further into the coronary artery, were required as sufficient support was not provided for such catheter issues.Additionally, the devices have resulted in dissections, prolongation of procedures, use of additional balloons or stents, operation failures, and vital complications because the balloon or stent could not be advanced.
Additional Manufacturer Narrative
B3: date of event - event date was reported as before february; therefore was approximated to (b)(6) 2021.
Event or Problem Description
It was reported that dissections occurred and additional intervention was required.Two 6f mach1 guide catheters were selected for use in procedures.The devices did not sufficiently support balloon or stent advancement in small, tough lesions and tortuous veins.The devices lost their hardness over time.In some cases, the guide catheter stuck to the insertion site sheath and would move the sheath during catheter movements.It was observed to lack inner diameter suitability to practically support easy double balloon or joint stent-balloon advancement.Additional steps, such as embedding the catheter further into the coronary artery, were required as sufficient support was not provided for such catheter issues.Additionally, the devices have resulted in dissections, prolongation of procedures, use of additional balloons or stents, operation failures, and vital complications because the balloon or stent could not be advanced.It was further reported that the dissection occurred during the stent passing stage.The dissected area was covered.The procedure was completed with another guide catheter.The patient's status was stable.

• Brand Name: MACH1
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11419234
• Report Number: 2134265-2021-02800
• Device Sequence Number: 2855349
• Product Code: DQY
• UDI-Device Identifier: 08714729351863
• UDI-Public: 08714729351863
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K020028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2021

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: 04/22/2022
• Device Model Number: 1260
• Device Catalogue Number: 1260
• Device Lot Number: 0060181436
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 04/26/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention