MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS VECTA 074 CATH 132CM - CE; CATHETER, THROMBUS RETRIEVER

Catalog Number INC-11989-132

Device Problem Fracture (1260)

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

Event Date 12/20/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : the device is not available to the manufacturer.

Event Description

It was reported that during a procedure subject aspiration catheter got stuck while advancing through the long sheath.Physician could neither advance nor retract the subject aspiration catheter so decided to retrieve the whole system out and found the shaft of the subject aspiration catheter broken in two parts.Surgical delay of seven minutes was observed.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully with another device.

Event Description

It was reported that during a procedure subject aspiration catheter got stuck while advancing through the long sheath.Physician could neither advance nor retract the subject aspiration catheter so decided to retrieve the whole system out and found the shaft of the subject aspiration catheter broken in two parts.Surgical delay of seven minutes was observed.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully with another device.

Manufacturer Narrative

H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿ updated.H3 summary attached - updated.D4 expiration date - added.D9 / h3 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, it was observed that the subject catheter was returned stuck inside the long sheath and later removed.The subject catheter was seen to be broken/fractured 89 cm from the hub, kinked and stretched.The subject catheter hub was intact.Functional testing could not be performed due to damage to the subject catheter.Catheter shaft was further damaged during patency mandrel testing (broken by the hub).The removal of the broken part from the long sheath required considerable effort and resulted in significant damage to the distal part of the subject catheter, which came out in pieces.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 as reported catheter shaft difficulty advancing, catheter shaft difficulty removing/withdrawing and catheter difficulty inserting could not be replicated during device analysis; however, the analysis results are consistent with the reported event.The catheter shaft broken/fractured during use code was confirmed.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The subject catheter was returned stuck inside of the long sheath.Dried blood was seen inside hub and catheter.The subject catheter's fractured part was stuck in the long sheath and later removed.The subject catheter shaft was seen to be broken/fractured 89 cm from the hub, the catheter was seen to be kinked and stretched.The catheter hub was intact.Therefore, the as reported can be confirmed.The presence of dried blood in the hub is an indication that insufficient flush might have been a factor in this complaint.The as reported codes catheter shaft difficulty advancing, catheter shaft difficulty removing/withdrawing, catheter shaft broken/fractured during use and catheter difficulty inserting as well as the analyzed codes catheter shaft broken/fractured during use, catheter shaft kinked/bent, catheter shaft stretched and catheter jammed will be assigned procedural factors as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.

• Brand Name: AXS VECTA 074 CATH 132CM - CE
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• Manufacturer (Section G): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 18443751
• MDR Text Key: 331886823
• Report Number: 3008853977-2024-00003
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K172167
• 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: 03/15/2024

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: Health Professional
• Device Expiration Date: 05/24/2024
• Device Catalogue Number: INC-11989-132
• Device Lot Number: 17296-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2023
• Initial Date FDA Received: 01/04/2024
• Supplement Dates Manufacturer Received: 02/22/2024
• Supplement Dates FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2021
• 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
• Treatment: AXS INFINITY LS PLUS LONG SHEATH (STRYKER).; SYNCHRO SELECT SUPPORT GUIDEWIRE (STRYKER).; VELOCITY MICROCATHETER (PENUMBRA).
• Patient Sex: Female