MAUDE Adverse Event Report: ENVOY 6F, MPC 90CM; PERCUTANEOUS CATHETER

Model Number	670-256-90
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient identifier is not known.The patient¿s age is not known.The patient's weight is not known.Concomitant med products: cordis 6f short sheath.(b)(6).The device has not been returned.If the device returns, a device investigation will be performed.Additional information will be submitted within 30 days of receipt.(b)(4).
Event or Problem Description
The health care professional reported that the envoy 6f, mpc 90cm guiding catheter (67025690 / 17707474) did not fit into the cordis 6f short sheath.The device was examined and it was reported that the distal tip of the guiding catheter appeared a little frayed, the noted issue is not conducive to smooth access.A new envoy 6f, mpc 90cm guiding catheter was used and the new guiding catheter was reported to fitted well.There was no report of patient injury or complication.
Additional Manufacturer Narrative
(b)(4).The health care professional reported that the envoy 6f, mpc 90cm guiding catheter (67025690/17707474) did not fit into the cordis 6f short sheath.The device was examined and it was reported that the distal tip of the guiding catheter appeared a little frayed, the noted issue is not conducive to smooth access.It was confirmed that there was no kink on the envoy catheter and excessive force was not used during the attempt to insert the catheter into the sheath.The sheath did not appear damaged.A new envoy 6f, mpc 90cm guiding catheter was used and the new guiding catheter was reported to fitted well.The reported event did not result in a significant clinical delay in the procedure; the delay was reported to be approximately 30 seconds to a minute.There was no report of patient injury or complication.The device history record (dhr) review for lot 17707474 was performed; it was noted that 30 units were rejected due to the defect damages in tips.This defect could be related to the reported complaint.However, during the review of the dhr for this lot, it was confirmed that the rejected units were properly segregated and discarded.There were no other issues noted that were considered to be potentially related to the reported complaint.The device has not been returned.If the device returns, a device investigation will be performed.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Product complaint # (b)(4).The health care professional reported that the envoy 6f, mpc 90cm guiding catheter (67025690 / 17707474) did not fit into the cordis 6f short sheath.The device was examined and it was reported that the distal tip of the guiding catheter appeared a little frayed, the noted issue is not conducive to smooth access.It was confirmed that there was no kink on the envoy catheter and excessive force was not used during the attempt to insert the catheter into the sheath.The sheath did not appear damaged.A new envoy 6f, mpc 90cm guiding catheter was used and the new guiding catheter was reported to fitted well.The reported event did not result in a significant clinical delay in the procedure; the delay was reported to be approximately 30 seconds to a minute.There was no report of patient injury or complication.The device has not been returned.If the device returns, a device investigation will be performed.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The health care professional reported that the envoy 6f, mpc 90cm guiding catheter (67025690 / 17707474) did not fit into the cordis 6f short sheath.The device was examined and it was reported that the distal tip of the guiding catheter appeared a little frayed, the noted issue is not conducive to smooth access.It was confirmed that there was no kink on the envoy catheter and excessive force was not used during the attempt to insert the catheter into the sheath.The sheath did not appear damaged.A new envoy 6f, mpc 90cm guiding catheter was used and the new guiding catheter was reported to fitted well.The reported event did not result in a significant clinical delay in the procedure; the delay was reported to be approximately 30 seconds to a minute.There was no report of patient injury or complication.The non-sterile envoy 6f, mpc 90 cm guiding catheter was received coiled inside a pouch.The device was visually inspected and observed kinked at 7.5 cm from the distal end.No other damages were observed on the device.The inner diameter (id) and outer diameter (od) were measured and found to be within specifications.Actual id: 0.070¿ specification: 0.070 ±.0005" minimum.Actual body od: 0.0826¿ specifications: 0.082 ± 0.0015¿.The envoy guiding catheter underwent functional analysis; it was flushed with water using a lab sample syringe (635-002).A 0.038¿ guidewire lab sample was introduced into the envoy guiding catheter and the guidewire was able to advance without any resistance until it reached the distal tip where resistance / friction was felt at the kinked section that was observed and noted during the visual inspection.The envoy guiding catheter was introduced into the lab sample 6f brite tip sheath and resistance / friction was encountered at the kinked section on the envoy guiding catheter but it could still be advanced until it reached the cannula distal tip.The reported issue of the distal tip appearing frayed was not confirmed during the visual analysis; no damage was observed.The reported issue with envoy 6f, mpc 90 cm guiding catheter not fitting into the cordis 6f short sheath was not confirmed during the functional test.The device history record (dhr) review for lot 17707474 was performed; it was noted that 30 units were rejected due to the defect damages in tips.This defect could be related to the reported complaint.However, during the review of the dhr for this lot, it was confirmed that the rejected units were properly segregated and discarded.There were no other issues noted that were considered to be potentially related to the reported complaint.The customer reported issue appeared to have been due to the kinked condition of the envoy 6f, mpc 90cm guiding catheter that was observed and noted during the visual inspection.The cause of the observed kinked section is most likely due to but not conclusively determined, excessive force applied on the device.Procedural factors and/or handling process may have contributed to the reported failure.The functional analysis and the review of the dhr for the lot 17707474 did not suggest that the reported failure is related to the manufacturing process.There are inspections in place to prevent failures such as the one reported from leaving the facility.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.Additional information will be submitted within 30 days of receipt.

• Brand Name: ENVOY 6F, MPC 90CM
• Common Device Name: PERCUTANEOUS CATHETER
• MDR Report Key: 7304546
• Report Number: 3008264254-2018-00510
• Device Sequence Number: 2378768
• Product Code: DQY
• UDI-Device Identifier: 10886704031710
• UDI-Public: (01)10886704031710(11)170629(17)200531(10)17707474
• Combination Product (Y/N): N
• PMA/510(K) Number: K000715
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/07/2018

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: 05/31/2020
• Device Model Number: 670-256-90
• Device Catalogue Number: 67025690
• Device Lot Number: 17707474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Initial Date Received by Manufacturer: 02/07/2018
• Supplement Date Received by Manufacturer: 02/07/2018; 02/07/2018; 02/07/2018
• Initial Report FDA Received Date: 02/28/2018
• Supplement Report FDA Received Date: 04/12/2018; 04/19/2018; 05/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1