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

Model Number INC-11597-132

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/11/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during the procedure the operator attempted to advance the microcatheter and micro wire through the subject catheter but resistance was felt.When the operator attempted to remove the subject catheter, more resistance was encountered.The operator pulled and the subject catheter came out.However, the subject catheter was broken and there was coil hanging from the catheter.The marker band and significant portion of the distal subject catheter remained inside the patient's artery.The physician used a catheter, retriever device and snare to attempt to remove the broken part of the catheter but was unsuccessful.No further information available.

Manufacturer Narrative

H4 manufacturing date ¿ added h3 device evaluated by mfg ¿updated h3 summary attached - updated d4 expiration date - added d9 product available to stryker ¿ updated d9 returned to manufacturer on ¿updated based on the results of the device history record (dhr) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.During visual inspection the catheter shaft was seen to be kinked/bent, flat/crushed and stretched from the catheter hub.The catheter shaft was seen to be broken/fractured from the catheter hub, the fractured part was not returned.The inner coil wind was seen to be exposed through the break.Functional inspection was not performed due to the damage noted to the device.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 reported defect ¿catheter shaft broken/fractured during use was confirmed during analysis.The reported defects ¿un-retrieved device fragments¿, ¿catheter shaft friction¿ and ¿catheter shaft difficulty removing/withdrawing¿ could not be replicated during device analysis; however, the analysis results are consistent with the reported event.Additional information provided by the customer indicated that physician attempted to remove the broken part of the catheter with the aspiration catheter, stent, and a snare.Following the submission of the medwatch form to the fda, stryker was queried about the product's label associated with the complaint.The fda noted a mismatched gtin on an affixed label for the subject catheter.Examination of provided images reveals this label was placed atop the correct one, revealing the proper gtin beneath.A thorough product history review indicates no re-labeling by stryker, and the queried product details don't exist in their systems, making rework or transactions impossible.The contract manufacturer assembling the subject catheter confirmed this label wasn't added at their facility.The reported defects ¿catheter shaft broken/fractured during use¿, ¿un-retrieved device fragments¿, ¿catheter shaft friction¿ and ¿catheter shaft difficulty removing/withdrawing¿ as well as the analyzed defects ¿catheter shaft kinked/bent¿, ¿catheter shaft broken/fractured during use¿, ¿catheter shaft flat/crushed¿ and ¿catheter shaft stretched¿ 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.

Event Description

It was reported that during the procedure the operator attempted to advance the microcatheter and micro wire through the subject catheter but resistance was felt.When the operator attempted to remove the subject catheter, more resistance was encountered.The operator pulled and the subject catheter came out.However, the subject catheter was broken and there was coil hanging from the catheter.The marker band and significant portion of the distal subject catheter remained inside the patient's artery.The physician used a catheter, retriever device and snare to attempt to remove the broken part of the catheter but was unsuccessful.No further information available.

• Brand Name: AXS VECTA 074 CATH 132CM - US
• 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: 17017040
• MDR Text Key: 316096544
• Report Number: 3008853977-2023-00021
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 07613327459265
• UDI-Public: 07613327459265
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INC-11597-132
• Device Catalogue Number: INC-11597-132
• Device Lot Number: 20138-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2023
• Initial Date FDA Received: 05/29/2023
• Supplement Dates Manufacturer Received: 08/14/2023
• Supplement Dates FDA Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2022
• 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: MICRO WIRE (UNKNOWN); MICROCATHETER (UNKNOWN); SNARE (UNKNOWN); SOFIA CATHETER (MICROVENTION); SOLITAIRE RETRIEVER DEVICE (MEDTRONIC)
• Patient Outcome(s): Required Intervention; Other