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

Model Number IC71132UG

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/14/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (30378166) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.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 during the left middle cerebral artery (mca) stroke procedure, a tracstar¿ guide catheter (imperative care) and a 132cm large bore 71 catheter (lbc) (ic71132ug / 30378166) were used.There was a tight 360 loop in the internal carotid artery (ica).The tracstar guide catheter was ¿parked¿ in the tight 360 loop and the lbc was advanced to the clot at the ica / m1 junction.Aspiration was applied to the clot and the lbc was retracted back to the guide.While pulling the lbc back into the guide, there was noticeable resistance.Once the lbc was pulled out of the tracstar guide catheter, the physician noticed stretching to the lbc catheter.It was reported that the thrombectomy procedure was proved successful with the first pass.There was no report of any patient injury.

Manufacturer Narrative

Manufacturerâ¿¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 17 december 2020.[additional information]: the healthcare professional reported that during the left middle cerebral artery (mca) stroke procedure, a tracstarâ¿¢ guide catheter (imperative care) and a 132cm large bore 71 catheter (lbc) (ic71132ug / 30378166) were used.There was a tight 360 loop in the internal carotid artery (ica).The tracstar guide catheter was â¿¿parkedâ¿¿ in the tight 360 loop and the lbc was advanced to the clot at the ica / m1 junction.Aspiration was applied to the clot and the lbc was retracted back to the guide.While pulling the lbc back into the guide, there was noticeable resistance.Once the lbc was pulled out of the tracstar guide catheter, the physician noticed stretching to the lbc catheter.It was reported that the thrombectomy procedure was proved successful with the first pass.There was no report of any patient injury.On 17 december 2020, additional information was received indicating that there was no excessive force applied / exerted on the complaint device.The device was taken out of the package correctly.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received by cerenovus product analysis lab on 18 january 2021.The returned product underwent evaluation and analysis.[conclusion]: the healthcare professional reported that during the left middle cerebral artery (mca) stroke procedure, a tracstar¿ guide catheter (imperative care) and a 132cm large bore 71 catheter (lbc) (ic71132ug / 30378166) were used.There was a tight 360 loop in the internal carotid artery (ica).The tracstar guide catheter was ¿parked¿ in the tight 360 loop and the lbc was advanced to the clot at the ica / m1 junction.Aspiration was applied to the clot and the lbc was retracted back to the guide.While pulling the lbc back into the guide, there was noticeable resistance.Once the lbc was pulled out of the tracstar guide catheter, the physician noticed stretching to the lbc catheter.It was reported that the thrombectomy procedure was proved successful with the first pass.There was no report of any patient injury.On 17 december 2020, additional information was received indicating that there was no excessive force applied / exerted on the complaint device.The device was taken out of the package correctly.The returned device underwent evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 132cm large bore 71 catheter (lbc) was received contained in a pouch.Visual inspection was performed.Residues of dried blood are noted on the device.The tip of the device is compressed.Dimensional measurements: the inner diameter (id) and outer diameter (od) of the device were measured and confirmed to be within specification.Hub id =.0715 inch; specification:.071 inch minimum.Distal id =.0715 inch; specification:.071 inch minimum.Actual microcatheter od = 0.0832 inch; specification: max.0.0837 inch / min.0.081 inch.A review of manufacturing documentation associated with this lot (30378166) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The complaint documented that during the left middle cerebral artery (mca) stroke procedure, a tracstar¿ guide catheter and the 132cm large bore 71 catheter were used.There was a tight 360 loop in the internal carotid artery (ica).The tracstar guide catheter was ¿parked¿ in the tight 360 loop and the lbc was advanced to the clot at the ica / m1 junction.Aspiration was applied to the clot and the lbc was retracted back to the guide.While pulling the lbc back into the guide, there was noticeable resistance.Once the lbc was pulled out of the tracstar guide catheter, the physician noticed stretching to the lbc catheter.The reported issue was confirmed during the analysis of the returned catheter.The tip was observed in compressed condition.The issue related to the resistance encountered during the attempt to withdrawal the lbc back into the guide could not be confirmed through the analysis and evaluation performed on the returned device; this is specific to and dependent on the procedure and the patient anatomy.The product analysis lab cannot duplicate a test environment to conduct functional testing for this issue.The compressed condition at the tip of the lbc is likely a contributing factor to the reported issue related to the resistance that was encountered during the attempt to withdrawal the lbc back into the guide.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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.H.6: investigation findings / investigation conclusions: the ¿no device problem found¿ code was used in the investigational findings because the resistance issue documented in the complaint could not be duplicated in the lab during the evaluation of the returned device.This code corresponds to the code ¿cause not established¿ code in the investigation conclusions.Updated sections: d.9, g.3, g.6, h.2, h.3, h.6, and h.10.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: 10969359
• MDR Text Key: 250091421
• Report Number: 3008114965-2020-00532
• 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,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/28/2021
• Device Model Number: IC71132UG
• Device Catalogue Number: IC71132UG
• Device Lot Number: 30378166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRACSTAR¿ GUIDE CATHETER (IMPERATIVE CARE)