MAUDE Adverse Event Report: CORDIS CORPORATION SLALOM PTA DILATATION CATHETER; PTA CATHETERS (LIT)

Catalog Number 4394040T

Device Problems Burst Container or Vessel (1074); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance per the applicable manufacturing quality plan.The product is available for evaluation and testing.However, the product has not been returned as of to date.Additional information will be submitted within 30 days upon receipt.

Event Description

As reported, during a percutaneous transluminal angioplasty (pta) the 40 cm.3.7 fr.Slalom thrill 4 x 4 balloon catheter (bc) was inflated twice up to its nominal pressure in the lesion.During its third inflation, the balloon ruptured approximately at its nominal pressure.When the product was withdrawn from the patient, approximately two (2) cm.Of the distal tip had separated and remained inside the patient.An attempt to snare the separated portion of the product was unsuccessful.Therefore the procedure finished without removing the separated portion.There was no reported patient injury.The product was clinically used and it will be returned for analysis.The physician questioned why the catheter had separated even though the balloon was ruptured vertically.Also he commented that the balloon could have been trapped by something.The target lesion was the anastomotic region of the left dialysis shunt.The lesion was reported to be: a 99% stenosis, moderately calcified and moderately tortuous.It was not reported as to whether the product issue being reported (besides the balloon burst) was distal tip or balloon separation.There was no reported withdrawal difficulty.The separated piece was in the patient铠elbow area.It is unknown if the physician is planning any additional intervention (such as stenting to secure the separated piece in place).It was unknown if the patient was symptomatic as a result of the reported separated product/reported product issue.The current status of the patient is unknown.There was no reported difficulty removing the product from the hoop.There was no reported difficulty removing the protective balloon cover.There was no reported difficulty removing the stylet or any of the sterile packaging components.There were kinks or other damages noted prior to inserting the product the product into the patient.The device prepped normally (i.E.Maintain negative pressure).The inflation device used was a non-cordis product and it was not known if it was used subsequently with other devices.The following information was requested but was reported to be unknown: was there any other product issue noted either at the account after the procedure or prior to shipping for inspection; what contrast media are you using (brand and manufacturer); what was the contrast to saline ratio; was there any resistance/friction while inserting the balloon through the rotating hemostatic valve; was there any resistance/friction while inserting the balloon through the guide catheter; was there difficulty advancing the balloon catheter through the vessel; was there difficulty crossing the lesion; was the catheter ever in an acute bend; did the balloon deflate normally; if deflation was not normal: how long did it take to deflate the balloon, did not deflate at all, how was the balloon eventually deflated; did the balloon re-wrap properly; did the balloon catheter kink while being used; are procedural films available if requested.No additional information is available.

Manufacturer Narrative

Additional information received: the product was returned for inspection.Additional information will be submitted within 30 days upon receipt.

• Brand Name: SLALOM PTA DILATATION CATHETER
• Type of Device: PTA CATHETERS (LIT)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5921001
• MDR Text Key: 53698727
• Report Number: 9616099-2016-00578
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K003159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 4394040T
• Device Lot Number: 16081408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE (AQUA VIII)
• Patient Outcome(s): Life Threatening; Required Intervention