MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR XT-17 STD STRAIGHT 150CM; CATHETER, PERCUTANEOUS

Model Number	M003C1775ST0
Medical Device Problem Codes	Fracture (1260); Peeled/Delaminated (1454); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system, there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned and the lot number was confirmed with the packaging and the device hub returned with the device.During visual inspection, the catheter shaft proximal end was seen to be damaged and have a hole present.The catheter hub and tip were both intact.During the functional inspection, the catheter was flushed and then a 0.0160" patency mandrel was attempted to be advanced through.It would not advance through the catheter hub, so the mandrel was then advanced distally and advanced through the catheter shaft without difficulty.When the mandrel reached the catheter hub it pushed out part of the catheter shaft and the ptfe inner lining.The reported event is covered in the device direction 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 defect was confirmed based on analysis of the device.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that the device was prepared for use as per the directions for use, there was no damage noted to the packaging prior to opening the packaging, the device confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was set up and maintained throughout the clinical procedure.The concurrent stent was deployed after the procedure by the physician and was found to be deformed.The damaged stent would have caused difficulty inserting into the catheter hub.The catheter shaft was found to be badly damaged and had a hole in the proximal shaft.There was ptfe inner liner and part of the catheter shaft removed from the catheter shaft.The ptfe liner peeling, part of the shaft fracturing and the damage noted to the catheter shaft would be due to the use of a needle when trying to insert the stent.The as reported event of catheter hub friction will be assigned caused by other as the damaged stent would have caused difficulty inserting into the catheter hub.The analyzed damage of the catheter shaft damaged, catheter shaft has hole/perforation, catheter shaft broke/fractured during use, ptfe coating peeling and catheter hub friction user error as the investigation confirms that there was an act or omission of an act that resulted in a different medical product response than intended by the manufacturer and/or expected by the user, a needle was used to try and advance the stent into the catheter hub.There is no reference in the dfu for the use of a needle to insert an intravascular device.
Event or Problem Description
The catheter (subject device) was returned for analysis and it was discovered that the shaft was damaged and had a hole in the proximal shaft.Ptfe inner liner and catheter (subject device) fragments were also present when the catheter was flushed.No clinical consequences were reported due to this event.No other information is available.

• Brand Name: EXCELSIOR XT-17 STD STRAIGHT 150CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 15710129
• Report Number: 3008881809-2022-00542
• Device Sequence Number: 14735513
• Product Code: DQY
• UDI-Device Identifier: 07613252714866
• UDI-Public: 07613252714866
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K142565
• 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): 11/01/2022

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: 03/20/2024
• Device Model Number: M003C1775ST0
• Device Catalogue Number: M003C1775ST0
• Device Lot Number: 23551422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2022
• 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: ATLAS STENT (STRYKER); ECHELON10 CATHETER (NON-STRYKER); GALAXY COIL (NON-STRYKER); MV2*6 (NON-STRYKER); SYNCHRO GUIDEWIRE (STRYKER); WEICHUANG (NON-STRYKER)
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Race: Asian