MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TRANSFORM COMPLIANT 5MM X 15MM - US; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number	M003SRC05150
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the additional embolization procedure of a 18 months previously treated area, the shaft of the subject balloon catheter was kinked and it was perforated by a guidewire.The shaft of the subject balloon catheter was fractured during retraction.Attempts were made to retrieve the broken fragment of the subject balloon catheter using the snare device but it was difficult to be removed.The broken fragment of the subject balloon catheter was left in the common hepatic artery.In doctor's opinion there was no risk of complications and would not impact the patient.He believes that the subject balloon catheter shaft may have been overloaded due to the meandering artery with high degree of arteriosclerosis.The procedure was completed successfully.The patient's condition is stable.
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during the additional embolization procedure of a 18 months previously treated area, the shaft of the subject balloon catheter was kinked and it was perforated by a guidewire.The shaft of the subject balloon catheter was fractured during retraction.Attempts were made to retrieve the broken fragment of the subject balloon catheter using the snare device but it was difficult to be removed.The broken fragment of the subject balloon catheter was left in the common hepatic artery.In doctor's opinion there was no risk of complications and would not impact the patient.He believes that the subject balloon catheter shaft may have been overloaded due to the meandering artery with high degree of arteriosclerosis.The procedure was completed successfully.The patient's condition is stable.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.D10 product available to stryker ¿ updated.D10 returned to manufacturer on ¿updated.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the balloon catheter shaft was seen to be kinked/bent from the balloon catheter hub.The balloon catheter shaft was seen to be broken/fractured from the balloon catheter hub.The distal fractured portion of the device was not returned.Functional inspection was not required.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 not given when the transform was taken out of the hoop, and the entire system was not flushed with a saline-contrast mixture during the preparation stages which may have contributed to the reported event.The device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu.Continuous flush was not set up and maintained throughout the clinical procedure and this may have contributed to the reported event.The doctor¿s opinion was that there was no risk of complications and that there would be no impact on the patient.He believes that the balloon catheter shaft may have been overloaded due to the approach to a meandering artery with a high degree of arteriosclerosis.During analysis, the balloon catheter shaft was seen to be kinked/bent.The balloon catheter shaft was seen to be broken/fractured.The distal fractured portion of the device was not returned.In the case of this complaint, it is probable that the distal transform device was broken/fractured during manipulation inside the high degree of arteriosclerosis vessel, and insufficient flush used during the preparations and use of the device, which resulted in the reported fracture.Therefore, the reported event was confirmed.The as reported ar defects balloon catheter broken/fractured during use', ' balloon catheter kinked/bent' and ' un-retrieved device fragment' and as analyzed aa defects balloon catheter broken/fractured during use and balloon catheter kinked/bent were assigned an assignable cause of procedural factors will be assigned as these issues are 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 and/or anatomical factors during use.

• Brand Name: TRANSFORM COMPLIANT 5MM X 15MM - US
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 16930997
• Report Number: 3008881809-2023-00248
• Device Sequence Number: 6720284
• Product Code: MJN
• UDI-Device Identifier: 07613327004472
• UDI-Public: 07613327004472
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/25/2023
• Device Model Number: M003SRC05150
• Device Catalogue Number: M003SRC05150
• Device Lot Number: 23182190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 07/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CHIKAI GUIDEWIRE (ASAHI); EN SNARE (UNKNOWN); TARGET COILS (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown