MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 2 MM X 2 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0035432020

Device Problem Premature Separation (4045)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

Subject device is not available.

Event Description

It was reported that during the procedure, when the subject coil was attempted to insert into the micro catheter, it stretched.The subject coil was retracted three times and on the third time it stretched inside the micro catheter.Then the subject coil detached unintentionally inside the micro catheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

Manufacturer Narrative

H4 manufacturing date ¿ added.D4 expiration date - added.The reported complaint could not be confirmed and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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.Additional information provided by the customer indicated that intermittent flush was maintained.It is probable that insufficient flush caused the event.As per the additional information, the patient¿s anatomy was very tortuous.It is probable that the device was damaged during advancement through the patient¿s anatomy.An assignable cause of procedural factors will be assigned to the reported events, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.

Event Description

It was reported that during the procedure, when the subject coil was attempted to insert into the micro catheter, it stretched.The subject coil was retracted three times and on the third time it stretched inside the micro catheter.Then the subject coil detached unintentionally inside the micro catheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET HELICAL ULTRA 2 MM X 2 CM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 9533053
• MDR Text Key: 176663786
• Report Number: 3008881809-2019-00413
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2020

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: 03/23/2022
• Device Catalogue Number: M0035432020
• Device Lot Number: 21314163
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 02/26/2020
• Supplement Dates FDA Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EXCELSIOR SL-10 MICRO CATHETER (STRYKER)
• Patient Age: 58 YR