MAUDE Adverse Event Report: COOK INCORPORATED MICROPUNCTURE; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number G48007

Device Problems Break (1069); Detachment Of Device Component (1104); Entrapment of Device (1212); Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/18/2018

Event Type  malfunction  

Event Description

During procedure catheter broke in patient, doctor consulted for retrieval, successfully removed.Cerebral angiogram with intervention.Catheter broke in artery.Consult to radiology interventional to retrieve.Subarachnoid hemorrhage -- cerebral angiogram with neurosurgeon.Dilator broke on attempt to remove from right common femoral artery after failed attempt to advance dilator.Doctor consulted intraprocedure and retrieved the broken dilator.Procedure continued after accessing the left common femoral artery.Using a micro puncture set to gain access in the groin area for a procedure, the tip of the micropuncture broke off and was logged close to the surface of the skin.A new micro puncture set was opened and used, access gained and the procedure completed without any further issues.Micropuncture introducer set silhouette transition less push-plus design stiffened cannula.

• Brand Name: MICROPUNCTURE
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7494221
• MDR Text Key: 107592422
• Report Number: 7494221
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Model Number: G48007
• Device Catalogue Number: MPIS-501-10.0-SC-NT-SST
• Device Lot Number: 8507990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/02/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 86 YR