MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN GUIDER 8F 90CM MULTI PURPOSE; CATHETER, PERCUTANEOUS

Model Number	H965100480
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The device was returned with no packaging, therefore the lot number was not confirmed.During visual inspection, there were no anomalies noted to the device.During the functional inspection, a patency mandrel was advanced, friction experienced at half way through catheter.White matter found to be ptfe lining from the inner lumen of the device, exited the distal end.The reported event is covered in the device directions for use (dfu).As well, 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.The reported event was confirmed during device analysis.The device failed to meet specification when returned.The device was returned and there was peeled ptfe lining noted to be occluding the inner lumen of the device, confirming the reported event.It is probable that the device inner lining was damaged during insertion of a guidewire or other intraluminal device during preparation of the device, causing the reported event.An assignable cause of handling damage will be assigned to the reported and analyzed catheter shaft blocked/occluded and to the analyzed catheter ptfe inner lining peeling and catheter friction.
Event or Problem Description
The device was returned for analysis and the investigation of the device revealed that the catheter (subject device) ptfe coating was peeling.No clinical consequences were reported to the patient due to this event.

• Brand Name: GUIDER 8F 90CM MULTI PURPOSE
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 14468940
• Report Number: 3008853977-2022-00027
• Device Sequence Number: 4570162
• Product Code: DQY
• UDI-Device Identifier: 08714729202523
• UDI-Public: 08714729202523
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 05/23/2022

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: 07/18/2024
• Device Model Number: H965100480
• Device Catalogue Number: H965100480
• Device Lot Number: 27687782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2001
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Race: Asian