MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY DAC 070 120CM - US; CATHETER, PERCUTANEOUS

Model Number	90771
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not yet returned.
Event or Problem Description
It was reported that during an acute thrombectomy treatment, the subject distal access catheter (dac) was used along with a microcatheter encountered difficulty advancing in the guiding catheter.The operator withdrew the whole system, and noticed big resistance between the subject catheter and the guiding catheter.It was also reported that the tip of the catheter (subject device) was fractured.The patient's anatomy was reported as moderately tortuous.The physician replaced it with a new device and complete the procedure successfully.There were no clinical consequences to the patient reported as a result of this event.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the catheter shaft was seen to be kinked bent at 62 cm from the catheter hub.The catheter shaft was seen to be flat/crushed from 101cm - 113cm.The catheter was broken/fractured at 120cm from the catheter hub.During function inspection, a mandrel was advanced but due to damage, resistance was noted.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 catheter was seen to be kinked bent, flat crushed and was also broken along the shaft.The as reported can be confirmed based on this as the physician may have interpreted the break at the tip instead of the shaft.The as reported 'nv - catheter shaft difficulty advancing', 'nv - catheter tip broken/fractured during use', ' nv - catheter shaft difficulty removing/withdrawing' as well as the as analyzed 'catheter shaft kinked bent', 'catheter shaft flat/crushed' and 'catheter shaft broken/fractured during use' 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.
Event or Problem Description
It was reported that during an acute thrombectomy treatment, the subject distal access catheter (dac) was used along with a microcatheter encountered difficulty advancing in the guiding catheter.The operator withdrew the whole system, and noticed big resistance between the subject catheter and the guiding catheter.It was also reported that the tip of the catheter (subject device) was fractured.The patient's anatomy was reported as moderately tortuous.The physician replaced it with a new device and complete the procedure successfully.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: DAC 070 120CM - US
• Common Device Name: 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: 12536374
• Report Number: 3012931345-2021-00159
• Device Sequence Number: 1140160
• Product Code: DQY
• UDI-Device Identifier: 07613327313963
• UDI-Public: 07613327313963
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133177
• 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): 01/19/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/18/2023
• Device Model Number: 90771
• Device Catalogue Number: 90771
• Device Lot Number: 0000059087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 12/27/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2021
• 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: 8F GUIDER CATHETER (STRYKER); SYNCHRO GUIDEWIRE (STRYKER); TREVO PRO-18 MICROCATHETER (STRYKER)
• Patient Sex: Male
• Patient Race: Asian