MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR XT-27 STD STRAIGHT 150CM; CATHETER, PERCUTANEOUS

Model Number	M003XT2750810
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the pica (posterior inferior cerebellar artery) aneurysm embolization procedure, after flushing the subject microcatheter, operator found that there was some problem with the ptfe inner lining peeling off the tip of the subject microcatheter and resistance was encountered at the tip of the subject catheter.Also, the entry and exit of the shaping needle were not smooth when shaping it.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated mes(manufacturing execution system) there are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspection: the catheter shaft was found to be kinked/bent approx.48cm, 64cm and 114cm from the catheter hub.The distal end of the catheter shaft was found to be crushed/flattened.The catheter shaft was found to be crushed/flattened in the zones approx.144.5cm-146.5cm, 24-32cm and at 6.5cm from the catheter hub.The catheter tip and hub were both intact.Functional inspection: a 0.027" pin gauge was verified to meet the catheter shaft when inserted into the catheter hub.The catheter was flushed and a 0.0265" patency mandrel was advanced through the microcatheter with friction felt in areas of damage.When the patency mandrel was advanced through the microcenter no sign of the ptfe inner lining coating was noted.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 ¿catheter ptfe inner lining peeling' was not 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 and there was no damage noted to the packaging prior to opening the packaging.The catheter distal shaft was found to be kinked and flattened which would have caused friction trying to advance the shaping mandrel.There was no ptfe inner lining peeling identified during analysis.The as reported ¿catheter ptfe inner lining peeling' will be assigned not confirmed.The as reported 'catheter shaft friction' and 'catheter tip poor shape retention' as well as the as analysed ¿catheter shaft kinked/bent¿, ¿catheter tip flat/crushed¿ and ¿catheter shaft friction¿ will be assigned handling damage as the damage identified would be due to handling of the product or portion upon removal of the product from the packaging, or preparation of the product prior to use.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that during the pica (posterior inferior cerebellar artery) aneurysm embolization procedure, after flushing the subject microcatheter, operator found that there was some problem with the ptfe inner lining peeling off the tip of the subject microcatheter and resistance was encountered at the tip of the subject catheter.Also, the entry and exit of the shaping needle were not smooth when shaping it.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: EXCELSIOR XT-27 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: 15415406
• Report Number: 3008881809-2022-00447
• Device Sequence Number: 19469131
• Product Code: DQY
• UDI-Device Identifier: 04546540698131
• UDI-Public: 04546540698131
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113778
• 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): 11/11/2022

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: 04/17/2024
• Device Model Number: M003XT2750810
• Device Catalogue Number: M003XT2750810
• Device Lot Number: 22876494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2021
• 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: EZ STENT(STRYKER)
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Race: Asian