MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 132CM LARGE BORE 71 CATHETER; CERENOVUS LARGE BORE CATHETER

Model Number IC71132UG

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.The product is available for evaluation and testing; however, it has not been received to date (which is indicated as "other").Additional information will be submitted within 30 days of receipt.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

As reported by the field, during a basilar posterior cerebral artery (pca) stroke, a radial approach was used.Started with 6f slender sheath that was inserted over wire, took out slender (used to dilate), placed cerebase da (bareback).Had to nick writs to get cerebase da in.A 132cm large bore 71 catheter (ic71132ug, 30386436) was prepped by the tech with a marksman microcatheter (mc) inside and synchro2 wire inside it.The user placed the large bore catheter (lbc), marksman, synchro into the cerebase da.The user gets the lbc to the face of the clot, removes both wire and microcatheter.The user attaches tubing to the jet engine pump, the nurse turns on the pump and they hear a ¿straw sucking sound¿.The sound was described as when a straw has a hole in it.The user retracts (pulls the lbc proximal out of the cerebase da) a few centimeters and notices the lbc is fractured.Quickly removes lbc and go back up with a jet7, marksman and synchro2 with no issue.

Manufacturer Narrative

Product complaint # (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, during a basilar posterior cerebral artery (pca) stroke, a radial approach was used.Started with 6f slender sheath that was inserted over wire, took out slender (used to dilate), placed cerebaseda (bareback).Had to nick writs to get cerebaseda in.A 132cm large bore 71 catheter (ic71132ug, 30386436) was prepped by the tech with a marksman microcatheter (mc) inside and synchro2 wire inside it.The user placed the large bore catheter (lbc), marksman, synchro into the cerebaseda.The user gets the lbc to the face of the clot, removes both wire and microcatheter.The user attaches tubing to the jet engine pump, the nurse turns on the pump and they hear a ¿straw sucking sound¿.The sound was described as when a straw has a hole in it.The user retracts (pulls the lbc proximal out of the cerebaseda) a few centimeters and notices the lbc is fractured.Quickly removes lbc and go back up with a jet7, marksman and synchro2 with no issue.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30386436 number, and no non-conformances related to the reported complaint condition were identified.With the information available and without the product available for analysis, the reported customer complaint of ¿catheter (body/shaft) - cracked-in patient¿ could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The cerebase instructions for use (ifu) states that an appropriately sized cerebase da guide sheath should be selected based on the patient anatomy and length.The ifu also cautions that if damage is detected, replace with another guide sheath, dilator, or hemostasis valve that is not damaged.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint devices, however, vessel size/characteristics, device selection, and operator technique, are potential contributing factors.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: 132CM LARGE BORE 71 CATHETER
• Type of Device: CERENOVUS LARGE BORE CATHETER
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 10385737
• MDR Text Key: 202358518
• Report Number: 3008114965-2020-00329
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10886704082378
• UDI-Public: 10886704082378
• Combination Product (y/n): N
• PMA/PMN Number: K191237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: IC71132UG
• Device Catalogue Number: IC71132UG
• Device Lot Number: 30386436
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CEREBASEDA; JET ENGINE PUMP; MARKSMAN MICROCATHETER; SYNCHRO2 WIRE; UNSPECIFIED 6F SLENDER SHEATH