MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN GUIDER/MP XF/8FR/90CM; CATHETER, PERCUTANEOUS

Model Number	H965100480
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during procedure, the guide catheter (subject device) distal radiopaque marker came off during embolization of a dural fistula.The operator changed the initial sheath to a 12f sheath and exchanged the guidewire.Then the operator inflated a 8 x 4 balloon inside the tip ring that broke off and managed to retrieve the tip from the patient.This was possible as the wire kept the radiopaque tip constrained inside the patient.There was 1 hour surgical delay.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
D4: expiration date: updated.H4: manufacturing date: updated.The device history record confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported issue is covered in the device directions for use.The risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.An assignable cause of undeterminable will be assigned to this complaint, as the product was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause.
Event or Problem Description
It was reported that during procedure, the guide catheter (subject device) distal radiopaque marker came off during embolization of a dural fistula.The operator changed the initial sheath to a 12f sheath and exchanged the guidewire.Then the operator inflated a 8 x 4 balloon inside the tip ring that broke off and managed to retrieve the tip from the patient.This was possible as the wire kept the radiopaque tip constrained inside the patient.There was 1 hour surgical delay.There were no clinical consequences to the patient.

• Brand Name: GUIDER/MP XF/8FR/90CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• MDR Report Key: 9448359
• Report Number: 3008853977-2019-00071
• Device Sequence Number: 14260723
• Product Code: DQY
• UDI-Device Identifier: 08714729202523
• UDI-Public: 08714729202523
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K980453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2020

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: 03/30/2022
• Device Model Number: H965100480
• Device Catalogue Number: H965100480
• Device Lot Number: 23569158
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/24/2019
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2F SHEATH (UNKNOWN MANUFACTURER); GUIDE WIRE (UNKNOWN MANUFACTURER)
• Outcome Attributed to Adverse Event: Required Intervention