MAUDE Adverse Event Report: COOK INC FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS; FED ENDOSCOPIC ACCESS OVERTUBE/GASTROENTEROLOGY-UROLOGY

Model Number	N/A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	09/23/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that during an unknown procedure the distal tip end of a sheath had deteriorated.Thus, leading to 2-3 cm of the patient's ureter being injured.A stent was placed in the patient's ureter in order to assist in the healing process.The patient did not experience any additional adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: clinical assessment: summary of the event: it was reported that ¿during the introduction of the sheath in the natural ways, the distal tip end has deteriorated.This has led to the patient's ureter injury of 2-3 cm.¿ and the ¿representative confirmed on 05 october 2016; according to the message of pharmacy, they put a stent into the ureter to practice healing.¿ clinical opinion of the event: based on the limited available information the exact cause of the issue is not clear for it may be contributed by patient¿s disease/clinical state, healthcare professional¿s technique/procedure, or the malfunction of the device itself.A review of the complaint history, device history record, documentation, specifications, trends, quality control and visual inspection of photos of the device was conducted during the investigation.According to the message of pharmacy, they put a stent into the ureter to practice healing.There is no indication that a design or process related failure mode contributed to this event.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The device was not returned for evaluation.A visual examination of the check-in photos appear to show that the tip is damaged.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS
• Common Device Name: FED ENDOSCOPIC ACCESS OVERTUBE/GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6050467
• Report Number: 1820334-2016-01121
• Device Sequence Number: 10782390
• Product Code: FED
• UDI-Device Identifier: 00827002348745
• UDI-Public: (01)00827002348745(17)190418(10)6897280
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K961904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2016

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: FUS-107045-P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2016
• Supplement Report FDA Received Date: 02/15/2017
• 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