MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS VECTA 046 CATH 146CM - US; CATHETER, THROMBUS RETRIEVER

Catalog Number INC-11814-146

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/20/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during the thrombus retrieval procedure, the catheter (subject device) was guided to the m2 and migrated when the microcatheter was being advanced to the peripheral.When the catheter (subject device) was placed in contact with the thrombus, the aspiration pump was used to aspirate the the thrombus and slowly pull the aspiration catheter out, a reverse bleeding near the internal carotid petrous potion was observed.Contrast was applied and a black object was observed in the anterior cerebral artery.When the catheter (subject device) was removed, the marker was not present on the device.Attempts were made to retrieve the remaining marker with a stent retriever and following that a microcatheter but both attempts were unsuccessful.Following this, a second microcatheter was reinserted to attempt to retrieve the remaining marker which resulted in the marker travelling further distally and remained in the anterior cerebral artery.Following this the procedure was completed.The patients condition is stable.No further information is available.

Event Description

It was reported that during the thrombus retrieval procedure, the catheter (subject device) was guided to the m2 and migrated when the microcatheter was being advanced to the peripheral.When the catheter (subject device) was placed in contact with the thrombus, the aspiration pump was used to aspirate the thrombus and slowly pull the aspiration catheter out, a reverse bleeding near the internal carotid petrous potion was observed.Contrast was applied and a black object was observed in the anterior cerebral artery.When the catheter (subject device) was removed, the marker was not present on the device.Attempts were made to retrieve the remaining marker with a stent retriever and following that a microcatheter but both attempts were unsuccessful.Following this, a second microcatheter was reinserted to attempt to retrieve the remaining marker which resulted in the marker travelling further distally and remained in the anterior cerebral artery.Following this the procedure was completed.The patients condition is stable.No further information is available.

Manufacturer Narrative

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 returned with the device.During visual inspection, the catheter shaft was seen to be kinked/bent approx.17 cm, 43 cm and 53 cm form the catheter hub.The catheter shaft was seen to be flat/ crushed between 10 cm and 39 cm from the catheter tip.The catheter distal shaft was seen to be damaged.The catheter tip was seen to be broken/fractured and the ro (radiopaque) marker band was missing.The inner coil wind was seen to be exposed through the fracture.There was a dried blood present inside of the catheter.Functional inspection was not carried out 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 complaint was confirmed based on analysis.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 flush was given when the product was taken out from the dispenser hoop, flush was given inside the microcatheter when inserting the guidewire.The device was prepared for use as per dfu, the device was 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 device was returned for analysis and the catheter shaft was seen to be kinked/bent, flat/crushed, the catheter distal shaft was seen to bed damaged, the catheter tip was seen to be broken/fractured and ro marker was found to be missing.The inner coil and stretched, the catheter shaft was seen to be broken/fractured and the fractured part was not returned.The inner coil wind was seen to be exposed through the break.The as reported events of ro marker(s) detached/separated/not visible under fluoroscopy, un-retrieved device fragments, device difficulty engaging target vessel and unexpected movement of device.As well as the assignable events of catheter shaft kinked/bent, catheter shaft flat/crushed, catheter shaft damaged, ro marker(s) detached/separated/not visible under fluoroscopy and catheter tip broken/fractured 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 046 CATH 146CM - 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: 17715646
• MDR Text Key: 323040112
• Report Number: 3008853977-2023-00036
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 07613327519365
• UDI-Public: 07613327519365
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/20/2023

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 Catalogue Number: INC-11814-146
• Device Lot Number: 20623-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 09/08/2023
• Supplement Dates Manufacturer Received: 11/14/2023
• Supplement Dates FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2022
• 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: DOMINANT FLEX PUMP (UNKNOWN); EMBOTRAP STENT (JOHNSON & JOHNSON); HEADWAY DUO MICROCATHETER (TERUMO); OPTIMO BALLOON GUIDE CATHETER (TOKAI MEDICAL); OPTIMO8F (TOKAI MEDICAL); PHENOM21 MICROCATHETER (MEDTRONIC); SYNCHRO SELECT STD (STRYKER)
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 87 YR
• Patient Sex: Female