MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 150CM 2 TIP; CATHETER, PERCUTANEOUS

Catalog Number M0031681890

Device Problem Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/26/2019

Event Type  malfunction  

Manufacturer Narrative

Subject device is not available.

Event Description

The physician found a hole on the microcatheter (subject device) so the physician pulled out the microcatheter.There were no clinical consequences to the patient.

Manufacturer Narrative

Expiration date: added, product available to stryker: updated, device evaluated by mfg: updated, mfg date: added.The device history record review confirms that the device met all material, assembly, and performance specifications.Visual and microscopic examination of the returned device found that the distal catheter shaft was kinked/bent and a hole perforation was noted at the distal tip.Functional testing was performed.The device was successfully flushed without any issues.The hub of the catheter was inspected using a 0.023¿ pin gauge and no issues were noted.Based on the analysis, the reported event was confirmed.Information available indicated that the device was confirmed to be in good condition prior to use.Based on the investigation results and available information, it is possible that during steam shaping of the device the distal shaft was damaged.Therefore, a cause of handling damages has been assigned to this investigation.

Event Description

The physician steam shaped the microcatheter.During preparation, the physician found a hole on the microcatheter (subject device).There were no clinical consequences to the patient.

• Brand Name: EXCELSIOR SL-10 150CM 2 TIP
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 8480502
• MDR Text Key: 140881550
• Report Number: 3008881809-2019-00088
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04546540688217
• UDI-Public: 04546540688217
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: K013789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/12/2019

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
• Device Operator: No Information
• Device Expiration Date: 10/08/2020
• Device Catalogue Number: M0031681890
• Device Lot Number: 20935697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/03/2019
• Supplement Dates Manufacturer Received: 05/28/2019
• Supplement Dates FDA Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1