MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY UNKNOWN_NEUROVASCULAR_PRODUCT; CATHETER, PERCUTANEOUS

Catalog Number UNK_NEU

Device Problem Fracture (1260)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/01/2020

Event Type  Injury  

Manufacturer Narrative

This 2 of 2 reports.Device is not available to manufacturer.

Event Description

Analysis of the catheter returned concluded that the metal parts that seem to be part of the product comes out when it was bent was not from the catheter.Based on the analysis and investigation, the metal parts might have been the parts of a balloon catheter (subject device) that broke during the procedure with an awareness date of 11-aug-2020.No clinical consequences were reported to the patient due to this event.

Event Description

Analysis of the catheter returned concluded that the metal parts that seem to be part of the product comes out when it was bent was not from the catheter.Based on the analysis and investigation, the metal parts might have been the parts of a balloon catheter (subject device) that broke during the procedure with an awareness date of 11-aug-2020.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

Although the dhr could not be reviewed because the lot number remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.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.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 the patient anatomy was very tortuous and no resistance encountered during the procedure.There was no product abnormality before use, and there were no procedural problems.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the device was not returned, a cause of 'undeterminable' shall be assigned to the as reported events.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 10489048
• MDR Text Key: 205524195
• Report Number: 3012931345-2020-00128
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K153729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AXS CATALYST 6 MICROCATHETER (STRYKER); HEADWAY MICROCATHETER (MICROVENTION); TREVO XP PROVUE RETRIEVER (STRYKER); AXS CATALYST 6 MICROCATHETER (STRYKER); HEADWAY MICROCATHETER (MICROVENTION); TREVO XP PROVUE RETRIEVER (STRYKER)
• Patient Age: 91 YR