MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 PRE-SHAPED 45 150CM; CATHETER, PERCUTANEOUS

Model Number M0031681900

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/05/2020

Event Type  malfunction  

Manufacturer Narrative

Subject device is not yet available.

Event Description

It was reported that during the procedure, the subject catheter was missing the distal 3cm radio opaque markers.The physician was unable to visualize subject catheter inside the patient anatomy.On inspection, the subject catheter was noticed to be buckled, and damaged proximal to the missing distal radio opaque markers section.The subject device was replaced and procedure was completed successfully without clinical consequence to the patient.

Manufacturer Narrative

Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.On initial inspection, the device was returned.The lot number was confirmed with the packaging returned with the device and the hub.On visual inspection, the catheter shaft was broken/fractured.The catheter distal shaft was not returned.The catheter shaft was wrinkled.The catheter hub was intact.Functional inspection was not required.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 device was returned for analysis and the catheter shaft was wrinkled and the catheter shaft was broken/fractured.The reported radio opaque marker missing will be assigned as not confirmed as the entire distal shaft was detached and not returned.The damage noted to the device would be indicative of the as reported defect.The as reported and as analyzed events will be assigned procedural factors as the defect appears to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural or anatomical factors during use.

Event Description

It was reported that during the procedure, the subject catheter was missing the distal 3cm radio opaque markers.The physician was unable to visualize subject catheter inside the patient anatomy.On inspection, the subject catheter was noticed to be buckled and damaged proximal to the missing distal radio opaque markers section.The subject device was replaced and procedure was completed successfully without clinical consequence to the patient.

• Brand Name: EXCELSIOR SL-10 PRE-SHAPED 45 150CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 10545021
• MDR Text Key: 207304599
• Report Number: 3008881809-2020-00267
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04546540688224
• UDI-Public: 04546540688224
• Combination Product (y/n): N
• PMA/PMN Number: K042568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2022
• Device Model Number: M0031681900
• Device Catalogue Number: M0031681900
• Device Lot Number: 22098210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRANSFORM BALLOON (STRYKER); TRANSFORM BALLOON (STRYKER)