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

Model Number	1260
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: no event date was provided, therefore, the first date of the month of the aware date was used.(b)(6).
Event or Problem Description
It was reported that the sterility of the device was compromised.A mach1 catheter-guide was delivered and upon removing from packaging, the sterile packaging of the product was opened.No patient involvement with this event.
Event or Problem Description
It was reported that the sterility of the device was compromised.A mach1 catheter-guide was delivered and upon removing from packaging, the sterile packaging of the product was opened.No patient involvement with this event.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The mach 1 was returned for analysis in the shipping pouch.The device was inspected for any damage or irregularities.The complaint was written about the shipping pouch being open upon delivery.The pouch was inspected and signs of it having been properly sealed were visible at the seal line, but it had been pulled apart.The device and pouch had been folded for return shipment back and this caused kinks in the catheter.The kinks were visible at the fold lines.The device was not removed from the pouch.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage.

• Brand Name: MACH1
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11751016
• Report Number: 2134265-2021-05482
• Device Sequence Number: 4138732
• Product Code: DQY
• UDI-Device Identifier: 08714729351986
• UDI-Public: 08714729351986
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2021

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: 10/04/2023
• Device Model Number: 1260
• Device Catalogue Number: 1260
• Device Lot Number: 0060261437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1