MAUDE Adverse Event Report: ANGIODYNAMICS SOFT-VU SIZING ANGIOGRAPHIC CATHETER

Catalog Number	H787107323025
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
As reported to angiodynamics on may 25, 2017: the physician was performing an angioplasty of the left leg.He was going up and over from the right groin.Patient had two existing iliac stents.The physician used an amplatz wire because he was worried about getting through the tortuous anatomy.When backing the sos omni catheter out of the patient, the wire got caught on one of the patient's stents.He used force to pull the wire back after he met resistance from the stent.Imagining showed that a portion of the radiopaque tip detached from the proximal end of the catheter.The physician was able to retrieve all pieces through the sheath and complete the procedure with no harm to the patient.The reported defective disposable device has been returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was a 4f soft-vu catheter.A visual review of the device noted a fracture near the tip, on the shaft of the device, and a fracture in the soft tip.The shaft fracture occurs 1.1cm from the weld joint.The soft tip fracture occurs 1.5cm from the tip.There is no sign on brittleness near the soft tip fracture.The device met all dimensional specifications.The customer's reported complaint description of soft-vu fracturing is confirmed.A definitive root cause for the reported complaint description cannot be determined, although it does not appear to be manufacturing related.The event description states that resistance was encountered when retracting the device through an existing stent in the patient.Continuing to retract while experiencing resistance is most likely the root cause to the fracture.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.The instructions for use, which is supplied to the end user with this catalog number, contains a statement; "do not insert catheters directly through synthetic vascular grafts.Insert through a sheath introducer.Never advance or retract an angiographic catheter or guidewire against resistance.This may result in damage to the vessel, the product, or both.Do not attempt to hand straighten the tip of any curved tipped catheters which are furnished with a tip straightener.This may result in damage to the product.Tip straighteners are furnished on all catheters intended to be straightened with the aid of a tip straightener.Reshaping of the catheter tip is not recommended.Physical damage to the catheter material can result when exposed to heat.When retracting catheters, great care must be taken to avoid exerting excessive pressure at the groin entry site.Excessive pressure may result in damage to the vessel, the catheter, or both" a review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint # (b)(4).

• Brand Name: SOFT-VU SIZING ANGIOGRAPHIC CATHETER
• Common Device Name: SOFT-VU SIZING ANGIOGRAPHIC CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 6653300
• Report Number: 1319211-2017-00068
• Device Sequence Number: 1285941
• Product Code: DQO
• UDI-Device Identifier: H787107323025
• UDI-Public: H787107323025
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K112452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2017

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: Physician
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: H787107323025
• Device Lot Number: 4961002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2017
• Supplement Date Received by Manufacturer: 05/25/2017
• Initial Report FDA Received Date: 06/20/2017
• Supplement Report FDA Received Date: 07/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1