MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 9FR 50CC INTRA- AORTIC BALLOOON PRODUCTS

Catalog Number IAB-R950-U

Device Problem Wrinkled (2614)

Patient Problems Myocardial Infarction (1969); No Consequences Or Impact To Patient (2199)

Event Date 09/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via a hot line call from the registered nurse (rn) in the cardiac cath lab (ccl) regarding a sheath issue upon insertion. The sheath with the side arm "accordion" on itself, when the md attempted to insert the intra-aortic balloon catheter (iab) via the femoral artery. The registered nurse said the md was not using any force during insertion and everything was standard procedure. They were able to remove the sheath and replace it with the alternate sheath in the tray without difficulty. There was a delay with no patient complications. The patient was stable on the intra-aortic balloon pump and transferred from the ccl.

Manufacturer Narrative

(b)(4). Returned for evaluation was an 11. 5fr sheath and dilator from an iab-r950-u insertion kit. The dilator was fully inserted within the sheath. Damage to the sheath tip was noted. Buckling of the sheath was noted from approx. 9cm to 10cm from the dilator tip. The dilator tip and hub appeared typical. The sheath hub appeared typical. The sheath sidearm was fully connected. Some clear fluid was noted in the sheath sidearm. Spots of dried blood were noted the exterior of the device. The dilator was easily removed from the sheath. The sheath was inserted into the t-tube and pressurized to 200mmhg. The sheath and sidearm did not leak. A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings. The device passed all manufacturing specifications prior to release. The reported complaint of sheath damaged is confirmed. Upon visual inspection, damage to the sheath tip and buckling of the sheath body were noted. The damage to the sheath appears to be consistent with insertion difficulty. The root cause of the complaint is undetermined.

Event Description

It was reported via a hot line call from the registered nurse (rn) in the cardiac cath lab (ccl) regarding a sheath issue upon insertion. The sheath with the side arm "accordion" on itself, when the md attempted to insert the intra-aortic balloon catheter (iab) via the femoral artery. The rn said the md was not using any force during insertion and everything was standard procedure. They were able to remove the sheath and replace it with the alternate sheath in the tray without difficulty. There was a delay with no patient complications. The patient was stable on the intra-aortic balloon pump and transferred from the ccl.

• Brand Name: REDIGUARD IAB: 9FR 50CC
• Type of Device: INTRA- AORTIC BALLOOON PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: anne rosenberger ; 2400 bernville road; reading, PA 19605 ; 6104783117
• MDR Report Key: 6026346
• MDR Text Key: 57308209
• Report Number: 1219856-2016-00225
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/16/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/31/2018
• Device Catalogue Number: IAB-R950-U
• Device Lot Number: 18F16G0017
• Other Device ID Number: 00801902010803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial