MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN GUIDER/MP XF/8FR/100 CM; CATHETER, PERCUTANEOUS

Catalog Number	M003101480
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
It was reported that during the stenting procedure at left vertebral artery for complex calcified 70% stenosis, the tip of the subject catheter was detached and stuck in the proximal part of the stent.When the physician advanced another catheter to the subclavian artery and advanced a wire through the stent, it was noticed that the detached tip was moving closer to the proximal end to the subclavian part of the stent.Therefore, the physician deployed another stent in the vertebra artery to lock the detached tip between the two stents.After the procedure, the patient was with 30% residual stenosis but free flow and no signs of the distal emboli.The patient was administrated with acetylsalicylic acid (asa) for lifetime, and clopidogrel for at least three months.No further information is available for now.
Event or Problem Description
It was reported that during the stenting procedure at left vertebral artery for complex calcified 70% stenosis, the tip of the subject catheter was detached and stuck in the proximal part of the stent.When the physician advanced another catheter to the subclavian artery and advanced a wire through the stent, it was noticed that the detached tip was moving closer to the proximal end to the subclavian part of the stent.Therefore, the physician deployed another stent in the vertebra artery to lock the detached tip between the two stents.After the procedure, the patient was with 30% residual stenosis but free flow and no signs of the distal emboli.The patient was administrated with acetylsalicylic acid (asa) for lifetime, and clopidogrel for at least three months.No further information is available for now.
Additional Manufacturer Narrative
Product available to stryker: updated.Expiration date: added.Returned to manufacturer on: updated.Concomitant products grid : updated.Device evaluated by mfg: updated.Summary attached: updated.Manufacturing date: added.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During the analysis of the returned device, it was revealed that the distal tip had been separated and the device appeared to have been ripped.Due to the nature of the complaint the functional evaluation was not performed.It is possible that the catheter tip may have caught onto an exposed portion of the stent during the clinical procedure causing it to become detached.However, this could not be definitively determined since the stent was not returned for analysis.Based on the results of the dhr (device history record) review, the reported event did not appear to have been manufacturing related.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of cause not established has been assigned to the reported event and analyzed anomalies.

• Brand Name: GUIDER/MP XF/8FR/100 CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• MDR Report Key: 8200093
• Report Number: 3008853977-2018-00081
• Device Sequence Number: 19353102
• Product Code: DQY
• UDI-Device Identifier: 08714729244356
• UDI-Public: 08714729244356
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2019

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: 03/10/2021
• Device Catalogue Number: M003101480
• Device Lot Number: 21913111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 02/13/2019
• 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: FIELDER XTR WIRE (ASAHI); FORMULA STENT (COOK MEDICAL)