MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENVOY DISTAL ACCESS GUIDING CATHETER; PERCUTANEOUS CATHETER

Catalog Number	67125805D
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).It is anticipated that the device will be returned for analysis; however, the device has not yet been returned.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, the tip of an envoy da catheter was found fractured during the procedure, prior to the device being placed in the patient.They used a new one to complete the procedure.There was no report of patient injury or procedure delay.It was reported that the device would be returned for analysis.
Additional Manufacturer Narrative
Device was returned for analysis on 6/12/2017; however, the analysis has not yet been completed.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Conclusion: as reported by a healthcare professional, the tip of an envoy da catheter was found fractured during the procedure, prior to the device being placed in the patient.They used a new one to complete the procedure.There was no report of patient injury or procedure delay.It was reported that the device would be returned for analysis.The envoy da was returned without the external box product, the internal pouch with the cardboard holder, the catheter¿s plastic protector, or the shipping container.A kink was found approximately 82.5 cm from the proximal end of the catheter shaft and compressions were found at approximately 18.0, 58.0, 60.0, and 61.0 cm from the proximal end.There was also evidence of dried blood residue at two locations near the distal end of the catheter.There was no evidence of a device fracture.No issues related to this product complaint were found in the dhr review executed for the device lot.The complaint that the catheter was fractured was not confirmed.Kinks and compressions were observed throughout the length of the catheter.Dried blood residue was also found along the catheter.Considering there is a 100% visual inspection where each unit is inspected for kinks, tip damage, contamination, etc.It is unlikely that a unit left the facility with kinks or residue visible by the unaided eye.No issues related to this product complaint were found in the dhr review executed for the device lot.Blood likely adhered to the catheter during the procedure and dried when the catheter was removed from the vessel.The most likely contributing factors to the damages found on the catheter tube are device handling or procedural factors such as tortuous vasculature although it cannot be determined how and when the damage occurred.Without the return of the distal outer sheath protector, the inner pouch, the inner cardboard product holder, the external product box, and the shipping container, it cannot be determined if this damage occurred with the end user, during storage at the distribution center, or in-transit.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.

• Brand Name: ENVOY DISTAL ACCESS GUIDING CATHETER
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6607689
• Report Number: 3004107186-2017-00001
• Device Sequence Number: 16282491
• Product Code: DQY
• UDI-Device Identifier: 10878528000676
• UDI-Public: (01)10878528000676(17)200131(10)E11438
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 67125805D
• Device Lot Number: E11438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Initial Date Received by Manufacturer: 05/10/2017
• Supplement Date Received by Manufacturer: 06/12/2017; 07/31/2017
• Initial Report FDA Received Date: 06/02/2017
• Supplement Report FDA Received Date: 07/07/2017; 07/31/2017
• Patient Sequence Number: 1