MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENVOY DA XB, 6F, 105CM, MPD; PERCUTANEOUS CATHETER

Model Number	671-258-05DB
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, ethnicity, and medical history were not provided.The name, phone and email address of the initial reporter are not available / reported.(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 (e12072) 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.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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 or Problem Description
The healthcare professional reported that the tip of the 105cm, 6f mpd envoy da xb (67125805db / e12072) was cracked.There was no report of any patient injury or complication.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to report that a re-review of the additional event information received on (b)(6) 2020 was performed.The reportability of the file was also reassessed.Based on the information provided, the tip of the 105cm, 6f mpd envoy da xb (67125805db / e12072) did not become cracked; the tip of the device was kinked.With this information, the file no longer meets the medical device reporting criteria as a malfunction.No further reports will be forthcoming.Updated sections: g.4, g.7, h.2, and h.10.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received by the product analysis lab on 3/25/2020.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.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.
Additional 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 tip of the 105cm, 6f mpd envoy da xb (67125805db / e12072) was cracked.There was no report of any patient injury or complication.Multiple attempts to obtain additional information related to the procedure and the reported device issue were unsuccessful.If additional information is received at a later date, this file will be updated accordingly.The product was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 105cm, 6f mpd envoy da xb was received contained in a pouch.Visual inspection was performed.Residues of dried blood was observed on the body of the envoy catheter; the catheter body was observed in good condition.The tip of the catheter was observed compressed and a clotted material was observed inside the distal tip of the catheter.No other damges were observed.Dimensional measurements were taken.The inner diameter (id) and the outer diameter (od) of the envoy da xb catheter were were measured and were confirmed to be within specifications.Hub id = 0.0715¿; specification: 0.071" minimum.Distal id = 0.0715¿; specification: 0.071" minimum.Od = 0.0823¿; specification: max.0.082¿ +/- 0.002¿.A review of manufacturing documentation associated with this lot (e12072) 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 documented that the tip of the 105cm, 6f mpd envoy da xb catheter was cracked.The reported issue was not confirmed based on the visual inspection performed on the returned device.The distal tip was observed compressed, but it was not observed to be cracked.The exact cause of the reported issue cannot be conclusively determined; however, the compressed distal tip observed on the returned envoy catheter is likely due to applied force.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.In addition, devices undergo inspection at final assembly to ensure that there are no damages such as the kinked areas observed on the returned microcatheter.Thus, it is unlikely that the 105cm, 6f mpd envoy da xb catheter left the manufacturing facility with the kinked areas observed on the body and near the distal tip during the visual inspection performed on the returned device.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: ENVOY DA XB, 6F, 105CM, MPD
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 9775656
• Report Number: 3008114965-2020-00024
• Device Sequence Number: 1866455
• Product Code: DQY
• UDI-Device Identifier: 10886704075097
• UDI-Public: 10886704075097
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/12/2020

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: 02/28/2022
• Device Model Number: 671-258-05DB
• Device Catalogue Number: 67125805DB
• Device Lot Number: E12072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 03/25/2020; 03/27/2020; 04/28/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 03/25/2020; 03/30/2020; 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1