MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO SELECT-14 SOFT PS 215CM; WIRE, GUIDE, CATHETER

Model Number	SSFT215PRE
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported after the procedure was completed the guidewire (subject device) coating was peeling in the middle.The procedure was completed successfully with no clinical consequences to the patient.
Event or Problem Description
It was reported after the procedure was completed the guidewire (subject device) coating was peeling in the middle.The procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.The lhr (lot history record) for each lot is created and maintained according to the qs (quality system).Controls within the qs ensure that all product is manufactured in accordance to the dmr (device master record).The device was returned and the lot number was not confirmed as the packaging was not returned with the device.During visual inspection it was seen an attempt had been made to shape the guidewire tip.The guidewire was noted to be kinked/bent at 53cm and 204cm from the proximal end.The guidewire ptfe coating was noted to be peeling in multiple areas to 93.5cm from the proximal end.The core wire distal end was observed through the distal tip dome.The guidewire was returned with ptfe peelings wrapped in medical gauze.Ptfe peeling was noted in the distal end of the returned introducer.Hydrophilic coating was hydrated there were no anomalies noted.Functional testing was not performed.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 event was confirmed based on the damage noted to the returned device.The device failed to meet specification when returned for analysis.Additional information indicates there was no damage noted to the packaging prior to opening the packaging, the device was confirmed to be in good condition during preparation/prior to use on the patient, the device was prepared for use as per the directions for use, continuous flush was set up and maintained throughout the clinical procedure.There was no resistance when the guidewire was taken out of the dispenser hoop.The guidewire was not shaped.Flush was not given inside the microcatheter at the time when the guidewire was inserted.There was no friction or resistance felt at the hub.The introducer sheath was used, when inserting the guidewire.It is unknown which part of the coating peeled off.The patient¿s anatomy was normal tortuous.Analysis of the returned device found the peeling/scraping is consistent with backloading the proximal end of the guidewire into the distal end of the introducer and pulling it through the introducer.The as reported and as analyzed event of the guidewire ptfe coating peeling in addition to the as analyzed event of the guidewire kinked/bent will be assigned handling damage as the issue is due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.

• Brand Name: SYNCHRO SELECT-14 SOFT PS 215CM
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer (Section G): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 13827129
• Report Number: 3012931345-2022-00050
• Device Sequence Number: 17259920
• Product Code: MOF
• UDI-Device Identifier: 07613327508598
• UDI-Public: 07613327508598
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K202522
• 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): 06/22/2022

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: 08/15/2023
• Device Model Number: SSFT215PRE
• Device Catalogue Number: SSFT215PRE
• Device Lot Number: 23109899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 03/19/2022
• Supplement Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SL -10 MICROCATHETER (STRYKER)
• Patient Sex: Unknown