MAUDE Adverse Event Report: MARTECH MEDICAL PRODUCTS, INC. DPIG HC 6X26; STENT, URETERAL

Model Number 5606026

Device Problems Delivered as Unsterile Product (1421); Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/25/2021

Event Type  malfunction  

Manufacturer Narrative

Due diligence was executed for this event.Supplemental report(s) will be filed as any additional information becomes available.The device has been returned and a device evaluation completed for it.Manufacture date is not known.The user¿s complaint was confirmed.A 5606026 double pigtail ureteral stent (lot mphy460) was returned for evaluation due to "crimped with hole in packaging".The user's complaint has been confirmed.The device was received in the original packaging.A visual inspection was performed on the received condition of the complaint device, and discovered numerous damages to the outer packaging.The damages include: indentations causing creases and a cut creating a breach in the package.Additionally, the sterile barrier around the edge is lifting up from the adhesive, also causing a breach in the package.The stent device inside of the package looks in disarray and damaged.Based on the evaluation, the likely cause of the damage to the sterile packaging of the stent device is due to, inadequate storing or shipping conditions.Per the device history record review the device was manufactured per specifications.There were no rejections, no ncr¿s (non conformance report), or amv (authorized manufacturing variance).Current standard operation procedures, quality assurance procedure and customer drawing specifications were followed.

Event Description

As reported for this event, the device was observed to be crimped with a hole in the packaging upon receipt.The device was not used.The device was not removed from the box.There is no patient involvement.

Manufacturer Narrative

This report is being supplemented to provide additional information based on review of complaint history investigation.A review of complaint history for model 5606026 found no other open complaints for this model that are related to the reported phenomenon.Olympus will continue to monitor complaints for this device.

• Brand Name: DPIG HC 6X26
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): MARTECH MEDICAL PRODUCTS, INC.; 1500 delp drive; harleysville PA 19438
• MDR Report Key: 11543110
• MDR Text Key: 250777098
• Report Number: 3003790304-2021-00053
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00821925004764
• UDI-Public: 00821925004764
• Combination Product (y/n): N
• PMA/PMN Number: K960148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/23/2021

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
• Device Operator: No Information
• Device Model Number: 5606026
• Device Lot Number: MPHY460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/22/2021
• Supplement Dates Manufacturer Received: 04/22/2021
• Supplement Dates FDA Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1