MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY MERCI BGC 9F X 95CM; CATHETER, PERCUTANEOUS

Catalog Number 90074

Device Problem Leak/Splash (1354)

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

Event Date 01/10/2024

Event Type  malfunction  

Event Description

It was reported that during a left internal carotid artery (ica) thrombectomy case, a balloon guide catheter was used to build access along with an aspiration catheter and it could not pass through the tortuous vessel, so a different model of aspiration catheter was used.Contrast agent was found leaking when dilating the tip of the subject balloon catheter and when retracted it was found damaged.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 and microscopic inspection, it was observed that the subject balloon catheter shaft had minor damage to the surface approximately 4.5cm distal to the distal end of the strain relief.The distal tip of the device was noted to be undamaged.There was a cut present in the subject balloon midway between the distal and proximal balloon inflation holes and the cut was 10.5mm from the distal tip of the subject balloon catheter.For function testing, the subject balloon was purged of air and an attempt was made to inflate the subject balloon.The subject balloon of the subject balloon catheter could not be inflated due to a leak noted at the mid-point between the distal and proximal inflation balloon holes.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 complaint codes 'balloon leaked during use' and 'balloon damaged' were both confirmed during device functional testing.The device did not met specifications when received for complaint investigation based on the visual and functional anomalies noted to the returned device.Additional information received from the customer indicates that the device was prepared for use as per the directions for use.There was no damage noted to the packaging prior to opening the packaging and the device was confirmed to be in good condition prior to use on the patient.Continuous flush was set up and maintained throughout the clinical procedure.The patient's anatomy was described as 'severely tortuous'.It was reported that the operator 'used 9f/95cm bgc (balloon guide catheter) to build access and delivered an aspiration catheter but it could not pass through the tortuous vessel.Changed to a 5f catheter one and then delivered a 3x30 retriever stent to the location.When dilating the tip of subject balloon guide catheter, the contrast agent leaked.The operator withdrew the balloon to check and found it damaged.Replaced it with another bgc 9f/95cm to dilate normally and continued the procedure'.In the follow-up good faith effort (gfe) process it was clarified by the user that the balloon was able to be successfully inflated and deflated during preparation and that the device was not inflated over the nominal pressure.The subject balloon catheter shaft was noted to be slightly damaged (although the damage was not severe enough to cause a kink) approximately 4.5cm distal to the distal end of the strain relief.The distal tip of the subject balloon catheter was undamaged.All of the relevant dimensional inspections passed.An attempt was made to inflate the balloon.The balloon could not be inflated due to the fluid immediately leaking from a cut on the balloon surface from a point midway between the proximal and distal balloon inflation ports/holes.Given that the balloon was successfully inflated and deflated prior to insertion into the patient, it is reasonable to assume that the damage occurred at some point following insertion of the balloon inside actually occurred.An assignable cause of procedural factors has been assigned to the as reported codes 'balloon leaked during use' and 'balloon damaged' and to the as analysed codes ¿balloon catheter damaged¿, ¿balloon leaked during use¿ and ¿balloon damaged¿ as this complaint appears to be associated with a product that met the manufacturers design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural and/or anatomical factors during use.

Event Description

It was reported that during a left internal carotid artery (ica) thrombectomy case, a balloon guide catheter was used to build access along with an aspiration catheter and it could not pass through the tortuous vessel, so a different model of aspiration catheter was used.Contrast agent was found leaking when dilating the tip of the subject balloon catheter and when retracted it was found damaged.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully with another device.

• Brand Name: MERCI BGC 9F X 95CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer (Section G): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 18595554
• MDR Text Key: 334177028
• Report Number: 3012931345-2024-00019
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00815742000740
• UDI-Public: 00815742000740
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K112404
• 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: 03/08/2024

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 Catalogue Number: 90074
• Device Lot Number: 0000200789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2024
• Initial Date FDA Received: 01/29/2024
• Supplement Dates Manufacturer Received: 02/20/2024
• Supplement Dates FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2022
• 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: REACT 71 CATHETER (MEDTRONIC).; SOFIA CATHETER (MICROVENTION).
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Race: Asian