MAUDE Adverse Event Report: PERFORMA ANGIOGRAPHIC CATHETER; DIAGNOSTIC CORONARY BYPASS CATHETER

Model Number	00884450000960
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during a percutaneous transluminal coronary bypass angioplasty [ptca] procedure, the catheter became kinked within the patient.The physician had successfully acquired retrograde arterial access and had negotiated the patient's vasculature under fluoroscopy with the 5f diagnostic catheter to cannulate and opacify the native coronary arteries/grafts.When the physician was attempting to remove the catheter post left heart diagnostic procedure, the catheter kinked.The cardiologist unsuccessful in removing the catheter form the patient.A radiologist was consulted to assist with the foreign body removal.The radiologist acquired secondary access via right femoral artery with a 7f sheath.A vascular snare device was used to successfully capture the retrieve the damaged catheter from the patient.Post-procedure the patient suffered an unrelated cardiac arrest event and was successfully resuscitated by the medical staff.Prolongation of hospitalization was deemed necessary by the physician.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed; however, the root cause is attributed to clinical use.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: PERFORMA ANGIOGRAPHIC CATHETER
• Common Device Name: DIAGNOSTIC CORONARY BYPASS CATHETER
• MDR Report Key: 10610046
• Report Number: 3011642792-2020-00011
• Device Sequence Number: 457817
• Product Code: DQO
• UDI-Device Identifier: 00884450000960
• UDI-Public: 00884450000960
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K943739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: 00884450000960
• Device Catalogue Number: 7534-23/B
• Device Lot Number: I1257509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 12/08/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2018
• 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: GUIDEWIRE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention