MAUDE Adverse Event Report: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODU YOGA 24, 0.024" ID, 150CM; CATHETER, PERCUTANEOUS

Catalog Number MC24150Z

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The name of the initial reporter is unknown.The manufacturer representative was provided as the initial reporter name.Information regarding patient weight, race, ethnicity, and medical history were not provided.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

As reported by an affiliate, during a coil embolization of an aneurysm at the acute ischemic stroke (ais) m2 expunction, a ace guiding catheter was take to the siphon, the yoga24 microcatheter (mc24150z, c42381) and the guidewire were approached to the lesion any were delivered without any problems.It was captured the distal end of the thrombus and the revive se (frs21452299, s12765) was delivered but only the tip came out from the yoga.The micro catheter was withdrawn and the guide wire was pressed but there was strong resistance felt.Therefore, the yoga and the revive were removed.Because the ace was gone up to m2, collection was completed with a direct aspiration first pass technique (adapt) and the procedure was completed successfully.The procedure was successfully completed without further issues, however, due to the event it was delayed for minutes.There was no patient injury or complications reported.The product will be returned for the investigation.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to the event.The guiding catheter, the ace, the yoga24 and the revive se were used as unit.The patient¿s vessel was mildly torturous and mildly calcified.A guiding catheter (cello, fuji systems co), and a y connector (terumo) were also used for this procedure.No further information is available.

Manufacturer Narrative

Product complaint # (b)(4).Additional information received clarified that the intended procedure was a thrombectomy for acute stage cerebral infarction.Thrombus was not present in the mc.Complaint conclusion: as reported by an affiliate, during a thrombectomy for acute stage cerebral infarction (acute ischemic stroke (ais) m2 expunction), a ace guiding catheter was take to the siphon, the yoga24 microcatheter (mc24150z, c42381) and the guidewire were approached to the lesion and were delivered without any problems.It was captured the distal end of the thrombus and the revive se (frs21452299, s12765) was delivered but only the tip came out from the yoga.The micro catheter was withdrawn and the guide wire was pressed but there was strong resistance felt.Therefore, the yoga and the revive were removed.Because the ace was gone up to m2, collection was completed with a direct aspiration first pass technique (adapt) and the procedure was completed successfully.The procedure was successfully completed without further issues, however, due to the event it was delayed for minutes.There was no patient injury or complications reported.The complaint products were new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and the constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to the event.The guiding catheter, the ace, the yoga24 and the revive se were used as unit.The patient¿s vessel was mildly torturous and mildly calcified.A guiding catheter (cello, fuji systems co), and a y connector (terumo) were also used for this procedure.Additional information received indicated that there was no thrombus percent.No further information is available.(b)(4): the device was returned connected to a (rhv) and a stopcock.There is no obvious external damage, and there are no visible kinks or compressed sections.An attempt was made to pass a lab 0.018 inch guidewire through the device.The guidewire passed through the microcatheter with no resistance or obstruction.An attempt was made to pass the revive thrombectomy device from this complaint (see (b)(4)) through the microcatheter.The revive device successfully passed through the microcatheter and completely exited the distal end.A request was made to evaluate the internal structure of the device by cutting the lumen and observing the interior directly.In order to assess the viability of the request, a crosswise test cut was made with a scalpel approximately 10 cm from the proximal end of the device.After several attempts, the scalpel was unable to fully penetrate the structure of the microcatheter.In addition, the pressure required to partially penetrate the microcatheter compressed the device.The metal mesh internal structure of the microcatheter was compressed and not completely severed by the scalpel cut.This result demonstrates that the internal structure of the device is damaged by cutting, and cannot be evaluated in that manner.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The complaint that the microcatheter is obstructed is not confirmed.Both a guidewire and the revive device from this complaint were able to pass through the microcatheter and exit the distal end.There is no visible damage to the device that would restrict passage of the revive through the microcatheter.The internal structure of the device cannot be directly evaluated, because cutting the device results in damage to the internal structure.Some debris was observed on the ball tip of the revive device (see (b)(4)).However, if this was due to an obstruction in the microcatheter, it would be expected to be changed (increased, removed, or relocated) when the revive device passed through the same obstructed section of the microcatheter again.No such change was observed.Therefore, it is unlikely that obstruction or damage to the microcatheter is the cause of the reported event.Based on the information available for review, there are vessel characteristics (calcification and tortuosity that may have contributed to the event reported.Based on the device history record 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 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: YOGA 24, 0.024" ID, 150CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODU; 3260 executive way; miramar FL 33025
• MDR Report Key: 7339681
• MDR Text Key: 102596949
• Report Number: 3008114965-2018-00564
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K171653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: MC24150Z
• Device Lot Number: C42381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Date Manufacturer Received: 03/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR