MAUDE Adverse Event Report: COOK IRELAND ZIMMON PANCREATIC STENT; FGE CATHETER, BILIARY, DIAGNOSTIC

Catalog Number SPSOF-5-3

Device Problem Insufficient Information (3190)

Patient Problems Unknown (for use when the patient's condition is not known) (2202); No Code Available (3191)

Event Type  Injury  

Event Description

Complaint information received is as follows; patient sustained catastrophic and permanent personal injuries.No further description of event or information on the patient outcome was received.

Manufacturer Narrative

The complaint product name provided was a pancreatic duct stent).The exact gpn, rpn or lot# is unknown.Any further details on in regards to the complaint issue, devices involved, procedure or patient condition are unknown.The device involved in the complaint was not available to be returned for evaluation.With the information provided a document based investigation was carried out.As the lot number of the device involved in this complaint was not provided, it was not possible to conduct a review of the device manufacturing records for this device.Prior to distribution all pancreatic duct stent devices are subjected to visual inspection and functional checks to ensure device integrity.The complaint was confirmed based on the customer testimony.This may change if any additional information is received.As the device has not been returned, as the device was not returned for evaluation and the conditions of device usage cannot be replicated in the laboratory, the cause of the complaint could not be conclusively determined.Pancreatic duct stent devices are used to drain obstructed pancreatic ducts.These devices are designed for single use only.As per instructions for use that accompany these devices, the users are cautioned as follows: "this device should not be left indwelling for more than three months or as directed by the physician.Periodic evaluation is recommended." complaints of this nature will continue to be monitored for emerging trends.

Manufacturer Narrative

This complaint is in relation to an spsof-5-3 (zimmon pancreatic stent) device of lot number c773100.As per the examination before trial (ebt) documents received 30-jul-15, the customers complaint suggests that the pigtail of the pancreatic stent did not coil/form as expected.The device involved in the complaint was not available to be returned for evaluation.With the information and images provided a document based investigation was carried out.As per the evidence given in the ebt, the pancreatic stent was allegedly modified prior to placement by removing (tearing off) the ductal flap.It was mentioned by the doctor in the ebt that he was unaware of an exact distance that one can or cannot be from the marker when it gets deployed.The complaint was confirmed based on the customer testimony but may change if any additional information is received.As the device has not been returned for evaluation, the cause of the complaint could not be conclusively determined.As per instructions for use that accompanies this device users are cautioned as follows: the tapered tip end of the stent must be positioned in the pancreatic duct while the other end remains in the duodenum.It also mentions: this device should not be left indwelling for more than three months or as directed by the physician.Periodic evaluation is recommended.In the notes section it mentions: use of this device restricted to a trained healthcare professional.In the instructions for use section it mentions under step 5 and 6: fluoroscopically and endoscopically confirm desired stent position.And after confirming stent position, gently remove wire guide from the endoscope while maintaining position of the stent with pushing catheter.Prior to distribution all spsof-5-3 devices are subject to visual inspection to ensure device integrity.A review of the manufacturing records for spsof-5-3 devices of lot c773100 did not reveal any discrepancies that could have contributed to the issue.Pancreatic duct stent devices are used to drain obstructed pancreatic ducts.These devices are designed for single use only.

Event Description

It has been alleged that the patient sustained catastrophic and permanent personal injuries.There is no other specific information or patient outcome.

Manufacturer Narrative

This follow up report is due to additional information received.The lot number c773100 and rpn spsof-5-3 were confirmed on (b)(6) 2015.The customer reported the following complaint issue."patient sustained catastrophic and permanent personal injuries.There is no other specific information or patient outcome." the complaint was confirmed based on the customer testimony but may change if any additional information is received.As the device has not been returned, the cause of the complaint could not be conclusively determined.As per instructions for use, ifu0055-2, users are cautioned as follows."this device should not be left indwelling for more than three months or as directed by the physician.Periodic evaluation is recommended." complaints of this nature will continue to be monitored for emerging trends.

Event Description

Patient sustained catastrophic and permanent personal injuries.There is no other specific information or patient outcome.

Manufacturer Narrative

Common device name: fge catheter, biliary, diagnostic.Pma/510(k) #: k900923.This follow-up report is being submitted due to the receipt of additional information (examination before trial (ebt) documents) received on 30-jul-15.

Event Description

It has been alleged that the patient sustained catastrophic and permanent personal injuries.There is no other specific information or patient outcome.

• Brand Name: ZIMMON PANCREATIC STENT
• Type of Device: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND; o'halloran road; national technology park; limerick ; EI
• Manufacturer Contact: sinead quaid ; o'halloran road; national technology park; limerick ; EI ; 061334440
• MDR Report Key: 4777056
• MDR Text Key: 20720795
• Report Number: 3001845648-2015-00104
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K900923
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative,hea
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/15/2015,09/08/2015

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SPSOF-5-3
• Device Lot Number: C773100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/15/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/20/2015
• Initial Date FDA Received: 05/15/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/31/2015; 08/28/2015; 10/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability