Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ATLAS PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BARD PERIPHERAL VASCULAR, INC. ATLAS PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number AT75186
Device Problems Material Frayed (1262); Peeled/Delaminated (1454); Material Puncture/Hole (1504); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/24/2018
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Expiry date (08/2021).The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
Event Description
It was reported that during an angioplasty procedure of a calcified lesion in the left common iliac vein, the pta balloon allegedly ruptured at 10atm during the third inflation attempt.The pta balloon was exchanged over the guidewire for another that was used to complete the procedure.There was no reported patient injury.
 
Event Description
It was reported that during an angioplasty procedure of a calcified lesion in the left common iliac vein, the pta balloon allegedly ruptured at 10atm during the third inflation attempt.The pta balloon was exchanged over the guidewire for another that was used to complete the procedure.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was returned for evaluation.A visual inspection found a small hole in the catheter shaft near the proximal glue joint.Therefore, the investigation is confirmed for a hole.The investigation is also confirmed for slight peeling of the outer pebax layer on the balloon.The device was inflated and water was noted to be exiting the balloon.The balloon fibers were stripped and a partial circumferential rupture was noted in the balloon material.Therefore, the investigation is confirmed for a circumferential rupture.It is likely that the circumferential rupture contributed to the identified peeled pebax.Per the reported event details, the patient's lesion was calcific and a wall stent was present.Therefore, it is unknown if patient factors or the wall stent contributed to the reported rupture.However, the definitive root cause for the rupture or hole in the catheter shaft could not be determined based upon the available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.( expiry date (08/2021).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ATLAS PTA DILATATION CATHETER
Type of Device
PTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key8280351
MDR Text Key134181710
Report Number2020394-2019-00073
Device Sequence Number1
Product Code LIT
UDI-Device Identifier00801741062506
UDI-Public(01)00801741062506
Combination Product (y/n)N
PMA/PMN Number
K120971
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 02/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAT75186
Device Catalogue NumberAT75186
Device Lot NumberGFCV1549
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2018
Date Manufacturer Received02/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age52 YR
Patient Weight64
-
-