MAUDE Adverse Event Report: COLOPLAST A/S ACCESS SHEATH CH10-12 45; URETHRAL ACCESS SHEATH

Model Number	AXXL101002
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we didn't find another complaint on this lot number.Checking the documentation process revealed that the finished product axxl12 (lot n°5328357) was made on feb 2016 for (b)(4) pieces.Checking the quality databases revealed no recorded abnormality in connection with the described incident.We received the sample and we observed it with the operators and workshop manager , we checked that the extremity of the sheath was too much cut.The root cause is due to human error during production.The manager re-sensitized the operators of this issue from july 2017.Based on the above, this complaint is confirmed as a product defect.
Event or Problem Description
According to the available information, opening of the mandrel in its distal part causing an exit of the guide during insertion - the clinical consequences for the patient: lesion of the ureter requiring a night of hospitalization while the patient was expected in ambulatory.

• Brand Name: ACCESS SHEATH CH10-12 45
• Common Device Name: URETHRAL ACCESS SHEATH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 6757696
• Report Number: 9610711-2017-00024
• Device Sequence Number: 13838202
• Product Code: FED
• UDI-Device Identifier: 03600040277508
• UDI-Public: 03600040277508
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K102485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: AXXL101002
• Device Catalogue Number: AXXL101002
• Device Lot Number: 5328357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 08/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other