MAUDE Adverse Event Report: MICROVENTION, INC. CHAPERON GUIDING CATHETER SYSTEM (5F)

Model Number	GC595M2VT
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned to the manufacturer; it was forwarded to terumo, as they are the actual device manufacturer.The investigation of the device and a review of the lot information is underway.
Event or Problem Description
It was reported that during treatment, a chaperon guiding catheter ruptured at the proximal end, outside of the patient.200ml of blood flowed back out of the ruptured segment of the catheter.No portion of the ruptured segment entered the patient's body.The device was exchanged for another catheter.There was no reported patient injury or intervention.
Additional Manufacturer Narrative
Review of the manufacturing record and the shipping inspection record of the involved product/lot# combination confirmed that there were not any indications of anomaly in them.A search of the complaint file found no other similar report with the involved product/lot# combination.Visual inspection of the actual sample upon receipt found that it had been damaged at approx.915mm from the distal end.Magnifying inspection of the damaged section found that the catheter had been twisted, and a part of it had been cracked and the inner layer had been exposed.The inner and outer diameters of the normal section were measured and confirmed to meet the specifications.Based on the investigation result, no anomaly was found in the dimensions and records of the actual sample.Moreover, before and after packaging of this product in the individual peel pack, 100% visual inspection is performed.Therefore, the following factor was inferred as a possible cause of this complaint.After opening the peel pack, bending force was applied to the catheter and the involved section was kinked.Torque force was repeatedly applied to the hub with the distal side trapped, then the kinked section was twisted, a part of it was cracked, and the inner layer was exposed.
Additional Manufacturer Narrative
The device was received by terumo japan, the actual device manufacturer, and the investigation of the device and a review of the lot information is currently ongoing.

• Brand Name: CHAPERON GUIDING CATHETER SYSTEM (5F)
• Common Device Name: GUIDING CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12367578
• Report Number: 2032493-2021-00340
• Device Sequence Number: 11734323
• Product Code: DQY
• UDI-Device Identifier: 00810170012372
• UDI-Public: (01)00810170012372(11)200827(17)230731(10)200827
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082385
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2021

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: 07/31/2023
• Device Model Number: GC595M2VT
• Device Catalogue Number: GC595M2VT
• Device Lot Number: 200827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 08/06/2021; 09/07/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 09/03/2021; 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 95