MAUDE Adverse Event Report: ANGIODYNAMICS SCHON BASIC DIALYSIS CATHETER; SCHON¿ HEMODIALYSIS DIALYSIS CATHETER SETS

Catalog Number	10801701
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
An end user reported an issue with a 14f x 15cm basic schon dialysis catheter.Post procedure, the schon catheter broke into 2 pieces while on the exchange wire, while a nurse practitioner was exchanging the schon temporary catheter into a tunneled permanent catheter ( routine practice/procedure) in the internal jugular vein using a nitrix guidewire.The device was removed by the surgeon, using a snare, and the pcad permanent device was placed.The patient did not experience any harm or adverse effects as a result of this incident.The reported device is not available to be returned to the manufacturer for evaluation at this time.
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation, however, a picture was provided showing the catheter tubing was detached approximately half-way between the suture wing and catheter tip.Scar004398 was sent to schon dialysis manufacturer and design owner, martech medical, to make them aware of this event and to perform review of dhr for reported lot number.Scar004398 response states, "after performing the dhr and process review were found that all the inspections and sequence of operations were properly followed and documented, additionally all the fixtures and the mold used in the manufacture of this part number were reviewed and no risk of damage was found and considering that the reported failure mode cannot be replicated, the reported failure mode is considered not attributable to the point medical west manufacturing processes." the customer's reported complaint of "the schon catheter broke into 2 pieces while on the exchange wire" was confirmedbased on the provided photo.Although the complaint was confirmed, a definitive root cause cannot be determined a review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Labeling review: instructions for use, which is supplied to the end user with this catalog number states: "do not use sharp instruments near the extension lines or tubing.Do not use scissors to remove dressing, as this could possibly cut or damage catheter.Do not suture any part of the catheter.Catheter tubing can tear when subjected to excessive force or rough edges.Use only smooth jaw forceps for clamping when not using the clamp supplied with the catheter.We recommend using only in-line extension clamps which have been provided for clamping.Clamping the catheter repeatedly in the same spot could weaken the tubing.Change the position of the clamp regularly to prolong the life of the tubing.Avoid clamping near the adapter and the hub of the catheter.Clamp only the extensions.Examine the tubing for damage at the end of each treatment".A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

• Brand Name: SCHON BASIC DIALYSIS CATHETER
• Common Device Name: SCHON¿ HEMODIALYSIS DIALYSIS CATHETER SETS
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 12605297
• Report Number: 1319211-2021-00067
• Device Sequence Number: 16497512
• Product Code: MSD
• UDI-Device Identifier: H787108017015
• UDI-Public: H787108017015
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K971925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/09/2023
• Device Catalogue Number: 10801701
• Device Lot Number: MPKY250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 29 KG