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

Model Number IC71132UG

Device Problems Stretched (1601); Deformation Due to Compressive Stress (2889)

Patient Problem Thromboembolism (2654)

Event Date 01/22/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, ethnicity, and medical history were not provided.A review of the manufacturing documentation associated with this lot (30445900) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Embolization of thrombus is a known potential complication during mechanical restoration of flow and thrombus removal procedures in which the large bore catheter is used.During these interventional procedures, the devices are advanced and withdrawn through pre-existing thrombotic lesions with risk of embolization of thrombus.The root cause of the event cannot be determined based on the information available for review; however, clinical, and procedural factors including clot burden, vessel characteristics, and device manipulation, may have contributed with no indication of a device malfunction.Since the event required medical intervention via stent retriever to assist in removing the fragmented clot to restore blood flow and prevent permanent injury, this event meets mdr reporting criteria as a ¿serious injury.¿ the manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

The healthcare professional reported that the (b)(6) year-old female patient with an occlusion in the left m1 segment of the middle cerebral artery (mca), no vessel tortuosity underwent an endovascular thrombectomy using a 132cm large bore catheter (lcb) (ic71132ug / 30445900).The standard adapt (a direct aspiration first pass technique) was used.The occlusion was engulfed with the lbc; during retracting, the clot fragmented and the lbc device ¿accordioned¿ and stretched.This occurred at approximately at 5cm from the distal tip.It was difficult to remove the fragmented clot and a stent retriever was used as an intervention.Additional information was received on 01 february 2021, indicated that the first pass was made via aspiration-only using the lbc device, then the issue occurred and the lbc was deemed unusable.The 3mm trevo® retriever (stryker) was then used as a rescue device.All the fragmented clot was removed.The reported event did not cause a clinically significant delay in the procedure as it is common practice to take 1 to 3 passes.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that the 38-year-old female patient with an occlusion in the left m1 segment of the middle cerebral artery (mca), no vessel tortuosity underwent an endovascular thrombectomy using a 132cm large bore catheter (lcb) (ic71132ug / 30445900).The standard adapt (a direct aspiration first pass technique) was used.The occlusion was engulfed with the lbc; during retracting, the clot fragmented and the lbc device ¿accordioned¿ and stretched.This occurred at approximately at 5cm from the distal tip.It was difficult to remove the fragmented clot and a stent retriever was used as an intervention.Additional information was received on 01 february 2021, indicated that the first pass was made via aspiration-only using the lbc device, then the issue occurred and the lbc was deemed unusable.The 3mm trevo® retriever (stryker) was then used as a rescue device.All the fragmented clot was removed.The reported event did not cause a clinically significant delay in the procedure as it is common practice to take 1 to 3 passes.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 132cm large bore catheter was received contained in a pouch.Visual inspection was performed.The device was observed with several flattened areas from 105 cm to 122 cm from the proximal end.The device was in stretched condition from 126 cm to 127 cm from the proximal end.No other damage / anomaly was observed.The device dimensions were measured.The inner diameter (id) and outer diameter (od) were within specifications.Hub id = 0.0715 inch; specification: 0.071 inch minimum.Distal id = 0.0715 inch; specification: 0.071 inch minimum.Actual microcatheter od = 0.0832 inch; specification: max.0.0837 inch / min.0.081 inch.A review of the manufacturing documentation associated with this lot (30445900) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The complaint reported that the 132cm large bore catheter (lcb) was used via the standard adapt (a direct aspiration first pass technique) during the procedure targeting an occlusion in the m1 segment of the middle cerebral artery.The occlusion was engulfed with the lcb and during retraction, the clot became fragmented and the lbc was ¿accordioned¿ and stretched at approximately 5 cm from the distal tip.The result was difficulty in the removal of the fragmented clot; a 3mm trevo® retriever was then used as a rescue device.The fragmented clot was removed.The reported issue was confirmed based on the visual inspection of the returned device.The id and od of the device were measured and found to be within specification.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be conclusively determined; however, it is possible that circumstances of the procedure and / or device manipulation / interaction may have contributed to the reported failure.Although no conclusion could be reached on the cause of the reported event, the instructions for use (ifu) contain the following precautions: carefully inspect all devices prior to use.Verify size, length, and condition are suitable for the specific procedure.Do not use a device that has been damaged in any way; replace with another large bore catheter.A damaged device may cause complications.Exercise care in handling the large bore catheter to reduce the chance of accidental damage.Embolization of thrombus is a known potential complication during mechanical restoration of flow and thrombus removal procedures in which the large bore catheter is used.During these interventional procedures, the devices are advanced and withdrawn through pre-existing thrombotic lesions with risk of embolization of thrombus.The root cause of the event cannot be determined based on the information available for review; however, clinical, and procedural factors including clot burden, vessel characteristics, and device manipulation, may have contributed to the reported event.Since the event required medical intervention via stent retriever to assist in removing the fragmented clot to restore blood flow and prevent permanent injury, this event meets mdr reporting criteria as a ¿serious injury.¿ as part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: 132CM LARGE BORE 71 CATHETER
• Type of Device: CATHETER, ASPIRATION CATHETER
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 11311882
• MDR Text Key: 234708886
• Report Number: 3008114965-2021-00065
• Device Sequence Number: 1
• Product Code: NRY
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: IC71132UG
• Device Catalogue Number: IC71132UG
• Device Lot Number: 30445900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3MM TREVO® RETRIEVER (STRYKER)
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR